FDA Patient LASIK Reviews and Adverse Events


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The following data shows a sample of the FDA filed data of adverse events following on from refractive surgery. These are the types of complications you can expect to have from refractive surgeries such as LASIK/LASEK(PRK)/IOL or even Relex (smile).

The vast majority of these people have been operated on by highly trained and qualified surgeons at well established clinics and have had the latest technology’s used on their eyes.

*(B)(4) – Text redacted by the FDA

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Report Date Event Date Adverse Events
1/31/2013 8/31/2012 Unkown
(B)(4). Conclusion (Other) – The Equipment Was Not Evaluated After The Treatment Date Which Occurred On (B)(6) 2011 Due To The Fact Abbott Medical Optics (Amo) Became Aware On (B)(4) 2013. The Condition Of The System (Since The Time Of The Procedure)

Report Date Event Date Adverse Events
1/28/2013 11/29/2012 BCVA, striae
Patient Underwent Uneventful Ilasik (B)(6) 2012. Presented For 2 Month Postop (B)(6) 2012 Complaining Of Change In Vision On Left Eye (Os). Slit Lamp Evaluation (Sle) Noted Striae Os. Elected To Lift And Stretch Flap Os. Visual Acuity Sans Corrected

Report Date Event Date Adverse Events
1/28/2013 12/15/2012 Epithileal ingrowth
Patient Had Lasik On The Right Eye (Od) At Different Site. Patient Came In For A Retreat Od On (B)(6) 2011. Patient Flap Was Lifted And Treated. Epithelial Ingrowth Was Discovered Od On (B)(6) 2012. Procedure Note On (B)(6) 2012, Extensive Ingrowth W

Report Date Event Date Adverse Events
1/25/2013 12/27/2012 Photophobia
An Optometrist Reported That A Pt Complained Of Photophobia And Burning Eyes. This Was Noted At Two Weeks Post Bilateral Lasik Surgery. Pt Noted Increased Burning With The Use Of "Blink Pf And Gel Tears". Noted Symptoms Were Reported To Have Been Exp

Report Date Event Date Adverse Events
1/24/2013 11/28/2012 Device malfunction
Customer Reported 1 Patient Interface ((B)(4)) Due To Multiple Suction Breaks. No Side Cut Was Created. The Surgeon Converted To Prk. Surgeon Completed Successfully The Left Eye (Os). There Was No Patient Injury.

Report Date Event Date Adverse Events
1/24/2013 7/1/2004 Dry eyes
Severe Dry Eye After Lasik Surgery. Must Use Eye Drops Each Morning To Be Able To Open The Eyes Every Day Since Surgery. Often Use Saline Drops During The Day As Well. On (B)(6) 2004 Ophthalmologist Diagnosed Severe Dry Eye Caused By Lasik Surgery At Lasik F/U Exam. Was Not A Preexisting Condition. Prescribed Daily Lubricating Drops And Nutritional Supplement. Was Reconfirmed At Each F/U Eye Exam Occurring Each Month Following The Lasik Procedure. (B)(6) 2004 – Again Diagnosed And Offered Treatment With Prescription "Restasis" (B)(6) 2013, By New Ophthalmologist.

Report Date Event Date Adverse Events
1/24/2013 7/1/2000 Dry eyes, NVD
After Receiving Lasik Eye Surgery From Dr (B)(6) In 2000 I Have Suffered From Dry Eye, Halo Effects Around Lights, And Poor Vision In Darkness. Furthermore, My Vision Has Gradually Deteriorated Since Receiving This Surgery, Despite Initial Improvemen

Report Date Event Date Adverse Events
1/24/2013 12/28/2012 Unkown
Note: All Pertinent Information Available To Amo At The Time Of This Report Has Been Submitted.

Report Date Event Date Adverse Events
1/21/2013 2/2/2012 NVD
I Had Undergone Lasik Surgery At (B)(6) Laser Eye Surgery Centers In (B)(6) Of 2012. After The Surgery My Vision Was Great During The Day, But I Have Problems With Night Vision. I Experience Starbursts, Halos, And Glare Around Lights, And Continued To Do So At Night. I Have Been To The Center For Check-Ups A Week After, Month After, 6 Months After, And The Doctor Assured Me That The Starbursts, Halos, And Glares Will Eventually Fade Away, However I Have Not Noticed Any Improvements Since The Surgery. On The Day Of The Last Check-Up, I Insisted To The Doctor To Correct The Problem. The Doctor Asked Me One Question And That Was If The Problems Affected My Driving At Night. The Side Effects Are Not Life Threatening, But The Problem Is So Severe And Disruptive. My Vision Bleeds And Sparks With Every Light Post, Car Light, Light Sign, And Other Bright Light In The Area. Even After I Described The Situation To The Doctor, She Replied That There Is Nothing She Can Do About It And That She Could Not Help Me Further. She Stated That 1-2% Of Lasik Candidates Experience These Problems. Note, I Went In 2 Times For A Diagnostics And Testing A Month Before The Surgery And Was Deemed A Great Candidate For Laser Custom Lasik. Custom Lasik Customvue. I Had Undergone Lasik Surgery At (B)(6) Laser Eye Surgery Centers In (B)(6) Of 2012. After The Surgery My Vision Was Great During The Day, But I Have Problems With Night Vision. I Experience Starbursts, Halos, And Glare Around Lights, And Continued To Do So At Night. I Have Been To The Center For Check-Ups A Week After, Month After, 6 Months After, And The Doctor Assured Me That The Starbursts, Halos, And Glares Will Eventually Fade Away, However I Have Not Noticed Any Improvements Since The Surgery. On The Day Of The Last Check-Up, I Insisted To The Doctor To Correct The Problem. The Doctor Asked Me One Question And That Was If The Problems Affected My Driving At Night. The Side Effects Are Not Life Threatening, But The Problem Is So Severe And Disruptive. My Vision Bleeds And Sparks With Every Light Post, Car Light, Light Sign, And Other Bright Light In The Area. Even After I Described …

Report Date Event Date Adverse Events
1/17/2013 3/26/2010 Depression-severe, NVD, HOA, corneal erosions
I Had An Elective Refractive Eye Surgery At (B)(6) And Did Not Receive The Custom Lasik Procedure I Paid For. On (B)(6) 2010, (B)(6) Of (B)(6) Personally Gave Me A Written Price Quote To Have A Custom Lasik Procedure Performed At His Facility. The Price Quote Specifically Listed The Procedure As Custom Lasik. There Was No Mention Of Conventional Lasik Or Any Other Procedure On This Document. There Was Also No Mention That The Procedure Could Or Would Be Changed W/O My Consent. Multiple Doctors Who Have Reviewed My Operative Reports From (B)(6) 2010, Have Verified That I Did Not Receive A Custom Lasik Treatment. The Conventional Lasik Treatment I Rec?D On (B)(6) 2010, Was Performed W/O My Knowledge Or Consent. The Doctors Responsible For My Care And Surgery Were (B)(6) Of (B)(6). The Timeline Of Events Does Not Support That Both The Optometrist And Ophthalmologist Were In Agreement On The Procedure That Would Be Performed At Time I Was Given The Price Quote Specifying Custom Lasik. Therefore, I Was Given A Quote That Misrepresented The Procedure I Would Receive, There Was A Gap In The Documentation And Communication Between (B)(6) Ensuring That I Would Receive The Custom Lasik Procedure I Was Quoted To Receive, Or Changes Were Made To My Treatment Plan W/O My Knowledge Or Consent. Regardless, I Did Not Receive The Procedure I Paid For. The Following Info Should Be Provided And Questions Should Be Answered: Dr (B)(6) Should Provide A Copy Of Either Price Quote That Was Distributed To Me On (B)(6) 2010, Or A Copy Of The Price Quotes That He Or His Staff Were Distributing During The Time Frame Of (B)(6) 2010. This Will Indicate If Dr (B)(6) Provided Unique Quotes Custom Vs. Conventional Lasik To Pts Based On His Assessment Of Their Health, Or If He Provided A Single Version Of The Quote To All Pts That Only Specified Custom Lasik As The Procedure, Indicating That Pts, Including Myself, Did Not Receive The Procedures We Expected To Receive And Paid For. The Quote Provided To Me By Dr (B)(6) Had A Unique Detail That I Will Disclose Separately Which Could Help Indicate If The Quotes Provided By Dr (B)(6) In Response To This Complaint Are Indeed The Same As Provided To Me On (B)(6) 2010. Did Dr (B)(6) Have Authority To Specify Which Procedure I Would Receive As A Pt Custom Lasik Vs. Conventional Lasik W/O Dr (B)(6)S Concurrence? If Dr (B)(6) Had Authority, How Did He Communicate To Dr (B)(6) That I Was To Receive Custom Lasik And Not Conventional Lasik? Is There Documentation Of This Communication? If Dr (B)(6) Did Not Have Authority To Specify The Procedure I Would Receive, Why Did He Give Me The Price Quote (B)(6) 2010 That Specifically Stated That I Would Receive A Custom Lasik Procedure? What Date Did Dr (B)(6) Agree On The Procedure I Would Receive? Why Did Dr (B)(6) Perform A Conventional Lasik Treatment When The Quote I Was Given By Dr (B)(6) Specified Custom Lasik? Why Did They Not Communicate Any Changes To The Treatment Plan To Me And Request My Consent Prior To Performing A Procedure Other Than Custom Lasik? There Was No Valid Reason For (B)(6) To Deviate From The Quoted Treatment Plan Of Custom Lasik W/O My Knowledge Or Consent. It Was Not As If This Was A Life Saving Procedure That Would Have Warranted A Deviation From The Quoted Procedure. This Was A Completely Elective Procedure With An Indefinite Amount Of Time To Discuss Potential Options. Dr (B)(6) Did Not Do This. (B)(6) Deviated From The Procedure I Paid For W/O My Knowledge Or Consent. My Life Altering Decision To Have Surgery Performed At (B)(6) Was Based Off Of Info Provided To Me By (B)(6) That Indicated I Would Receive Custom Lasik. (B)(6) And His Staff Have Continually Refused To Provide To Me With A Copy Of The Price Quote They Gave Me, As They Were Aware That The Quote Provided To Me On (B)(6) 2010 Specified Custom Lasik And This Document Will Be Presented As Evidence Against Them. I Now Wear A (B)(6) Pair Of Custom Made Scleral Lenses To Help Correct My Vision And To Help Prevent The Recurring Corneal Erosions That Are A Result Of Having Lasik Complications. I Paid For These Lenses Out Of Pocket As My Medical And Vision Insurance Did Not Cover Such Costs. I Am Now Faced With A Lifetime Of Vision Complications And The Significantly Increased Cost Of My Vision Care. I Also Have The Added Burden Of Continued Mental Health Care Due To The Severe Depression I Have Suffered From For Over Two Yrs As A Direct Result Of Having My Vision Damaged And My Lifestyle And Career Options Being Limited. I Had No Prior History Of Vision Problems, Depression, Or Any Mental Health Concerns Prior To Having My Vision Damaged. I Am Unable To Perform All Of My Job Duties Due To My Poor Vision. I Am Only (B)(6) And Must Be Able To Continue Working For Many Yrs Before Being Eligible To Retire. Please Consider There Is A Real Person Filing This Complaint. I Had Goals That I Can No Longer Achieve And Hobbies I Can No Longer Participate In As A Direct Result Of The Surgery They Performed That I Never Agreed To. I Have A Wife I Have Been Married To For Over Ten Yrs. We Had Plans Together That Have Been Derailed. My Damaged Vision Has Had An Effect On Us That Is Impossible For Me To Convey. I Am Unable To Escape From My Damaged Vision. It Interferes With Every Aspect Of My Life. My Night Vision Has Been Ruined With Halos, Starbursts, Glare, And Multiple Images. I Must Also Travel Frequently As Part Of My Job. I Am Losing The Ability To Safely Drive At Night Which Limits My Travel Arrangements. Prior To Receiving Conventional Lasik At (B)(6), I Had Worn Cheap, Disposable Soft Lenses For More Than 15 Yrs And Never Had One Single Issue With My Vision Or Eye Health. Or Missed One Single Day Of Work Due To My Vision. I Could Have Been Seen By Any Optometrist And Picked Up A Box Of Lenses The Same Day. My Treatment Is Now? I Had An Elective Refractive Eye Surgery At (B)(6) And Did Not Receive The Custom Lasik Procedure I Paid For. On (B)(6) 2010, (B)(6) Of (B)(6) Personally Gave Me A Written Price Quote To Have A Custom Lasik Procedure Performed At His Facility. The Price Quote Specifically Listed The Procedure As Custom Lasik. There Was No Mention Of Conventional Lasik Or Any Other Procedure On This Document. There Was Also No Mention That The Procedure Could Or Would Be Changed W/O My Consent. Multiple Doctors Who Have Reviewed My Operative Reports From (B)(6) 2010, Have Verified That I Did Not Receive A Custom Lasik Treatment. The Conventional Lasik Treatment I Rec?D On (B)(6) 2010, Was Performed W/O My Knowledge Or Consent. The Doctors Responsible For My Care And Surgery Were (B)(6) Of (B)(6). The Timeline Of Events Does Not Support That Both The Optometrist And Ophthalmologist Were In Agreement On The …

Report Date Event Date Adverse Events
1/17/2013 12/18/2012 DLK
On (B)(6) 2012, Doctor Reported Patient With Trace Dlk (Diffuse Lamellar Keratitis) On Both Eyes (Ou). No Lift And Rinse Was Performed. PatientS Predforte Was Increased. No Loss Of Best Corrected Visual Acuity Was Reported. Uncorrected Visual Acuity

Report Date Event Date Adverse Events
1/17/2013 11/15/2012 DLK
A Technician Reported An Undisclosed Number Of Patients That Developed Dlk (Diffuse Lamellar Keratitis) The Day After Lasik Surgery. The Post-Op Regime Was Not Changed And The Dlk Was Said To Be Resolving In (B)(6). The Final Resolution Cannot Be Con

Report Date Event Date Adverse Events
1/16/2013 Unkown
Note: All Pertinent Information Available To Amo At The Time Of This Report Has Been Submitted. (B)(4): Placeholder.

Report Date Event Date Adverse Events
1/15/2013 3/15/2012 Unkown – clinic did not report AE to manufacturer
The Clinic Did Not Report This Adverse Event To The Manufacturer. There Was No Request For Field Service Or Clinical Support At Or Around The Time Of The PatientS Adverse Event Or As A Result Of The PatientS Adverse Event. All Pertinent Information

Report Date Event Date Adverse Events
1/14/2013 9/15/2012 DLK
An Optometrist Reported That A Patient Underwent A Prk (Photorefractive Keratectomy) Enhancement For Previous Lasik (Laser Insitu Keratectomy). On The First Day After The Prk Enhancement, The Patient Was Diagnosed With Stage 1 Dlk (Diffuse Lamellar K

Report Date Event Date Adverse Events
1/14/2013 12/15/2012 Striae
While Abbott Medical Optics Clinical Development Manager Cdm Provided Surgery Support, The Doctor Had A Patient Return For A One Day Post-Op With Striae On Both Eyes (Ou). Patient Pre-Op Best Corrected Visual Acuity (Bcva) 20/20; Uncorrected Visual A

Report Date Event Date Adverse Events
1/11/2013 12/1/2012 BCVA
An Optometrist Reported That A Patient Who Underwent Lasik For Monovision. The Eye That Was Treated For Distance Vision Was Little Myopic At One Day Post-Op, And Remained So At One Week Post-Op. The Patient Reported That She Could Not Drive, So She W

Report Date Event Date Adverse Events
1/11/2013 2/9/2009 Cataracts
I Had Lasik Surgery Four Years Ago. My Surgery Went Well, But After Three Years, Developed Bad Cataracts. I Have Had One Removed With Great Results And Am Having The Other Removed Next Month. I Can See Very Well Out The One Eye, I Hope It Goes As Well With The Other. I Would Advise Anyone Over 40 To Not Have Lasik Surgery. I Really Think This Is What Caused Them. I Am (B)(6).

Report Date Event Date Adverse Events
1/11/2013 12/11/2012 Device malfunction
Customer Reported 1 Patient Interface (B)(4) Due To Lack Of Suction Prior To The Laser Firing. Treatment Was Aborted And Patient Was Switched To Photorefractive Keratectomy (Prk). The Suction Issue Was Not Caused By Excessive Fluids On The Eye. There

Report Date Event Date Adverse Events
1/11/2013 12/7/2012 DLK
Customer Reported That There Were Three Patients On (B)(6) 2012 With Diffuse Lamellar Keratitis (Dlk) Grade 3-4 And Two Patients The Week Before. All Five Went Through A Lift And Rinse Procedure, And Have Since Been Cleared With No Loss Of Best Corre

Report Date Event Date Adverse Events
1/11/2013 12/14/2012 Unkown
Investigation, Including Root Cause Analysis, Is In Progress. A Supplemental Mdr Will Be Filed As Necessary In Accordance With 21 Cfr 803.56 When Additional Reportable Information Becomes Available. (B)(4).

Report Date Event Date Adverse Events
1/9/2013 12/10/2012 DLK
An Optometrist Reported That A Patient Who Underwent Bilateral Lasik Was Diagnosed With Trace Dlk (Diffuse Lamellar Keratitis) In Both Eyes On The Second Post-Op Day. The Steroid Drops Were Increased, Which Resolved The Dlk, And The Uncorrected Va Is

Report Date Event Date Adverse Events
1/8/2013 1/6/2012 Retina detachment, cataracts
Six Months After Having Lasik Surgery, I Woke Up Blurry In My Left Eye, Went To Lasik Doctor Thinking I Needed An Adjustment. He Tells Me I Have A Detached Retina From 2-8 O?Clock-Half My Retina Is Detached. I Didn?T Get Hit Or Poked In My Eye. I Woke Up That Way. I Have A Surgery On (B)(6) 2012. A Full Sclera Buckle Is Attached With A Gas Bubble, Out Of Work 6 Weeks. I Go Back For One Of Many Follow-Ups In (B)(6) And Retina Doctor Sees Tear In My Right Eye. He Says He Can Fix It In A Minor 5 Minute Laser Surgery To Fuse The Tear And I Will Not Have To Do The Retina Surgery. I Agreed. (B)(6) I Am In For Follow-Up And Now He Sees Fluid Behind Retina In Right Eye And Need Emergency Surgery Next Day. They Put A Half Buckle On My Right Eye. So, For 6 Months I Had Great Vision. Now I Am Near-Sighted In My Left And Not Back To Where I Was With Lasik In My Right. I Am Also Getting Double Vision In My Left Eye And The Retina Doctor Says That It Is Cataracts Advancing And I Will Need Surgery Within The Year. Something Has To Be Done. I Was A Perfect Candidate, Passed All Tests. Both Lasik And Retina Doctor Say, ?It Happens?. I Don?T Think So. There Was A Slip Of The Laser Or Not Calibrated Correctly, Or Something. This Needs To Be Looked Into As Soon As Possible. I Am Finding I Am Not The Only One. Six Months After Having Lasik Surgery, I Woke Up Blurry In My Left Eye, Went To Lasik Doctor Thinking I Needed An Adjustment. He Tells Me I Have A Detached Retina From 2-8 O?Clock-Half My Retina Is Detached. I Didn?T Get Hit Or Poked In My Eye. I Woke Up That Way. I Have A Surgery On (B)(6) 2012. A Full Sclera Buckle Is Attached With A Gas Bubble, Out Of Work 6 Weeks. I Go Back For One Of Many Follow-Ups In (B)(6) And Retina Doctor Sees Tear In My Right Eye. He Says He Can Fix It In A Minor 5 Minute Laser Surgery To Fuse The Tear And I Will Not Have To Do The Retina Surgery. I Agreed. (B)(6) I Am In For Follow-Up And Now He Sees Fluid Behind Retina In Right Eye And Need Emergency Surgery Next Day. They Put A Half Buckle On My Right Eye. So, For 6 Months I Had Great Vision. Now I Am Near-Sighted In My Left And Not Back To Where I Was With Lasik In My Right. I Am Also Getting Double Vision …

Report Date Event Date Adverse Events
1/4/2013 4/1/2001 Ectasia
I Have Post-Lasik Ectasia And My Insurance Company Will Not Cover The Procedure Recommended Intacs, Keratoplasty, And Uv Collagen Treatment By My Doctor, Dr. (B)(6). Numerous Visits To Ophthalmologist, Had To Spend About (B)(6) On Procedure So Far. Uv Collagen Crosslinking.

Report Date Event Date Adverse Events
12/21/2012 10/16/2012 Device malfunction
A Technician Reported That During A PatientS Laser Treatment, The Laser Stopped Firing At 81%. A System Message Was Displayed Indicating There Was A Shutter Error, And The Laser Was Rebooted. Upon Follow Up, The Technician Stated That The Case Invol

If you have had a bad outcome then please speak out by reporting your complication. People are suffering, if you are willing to stand up to help them and prevent others from going through the same problems, or if you have had surgery and are unhappy to find out that the lasik flap can be easily dislodged for the rest of your life, or that the clinic used toxic MMC in your eyes, then please sign the petition! We need YOUR help!