MAUDE Adverse Event Report: STAAR SURGICAL COMPANY STAAR SURGICAL MICL 12.6 ; INTRAOCULAR LENS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Cataract (1766)

Event Date 06/17/2009

Event Type  Injury  

Event Description

I planned to have bilateral intraocular lens implants done by dr (b)(6) ((b)(6) institute) in (b)(6) at (b)(6) hospital on (b)(6) 2009.I don't remember which one was implanted first, but i got a staar surgical micl 12.6 implanted to the right eye.During the left eye insertion, i remember a lot of "ooops" and "oh, no's" and scrambling around to fix something.They ended up putting a crystalens at-52se lens in my left eye.Dr (b)(6) explained later that i got a better cataract lens in that eye which replaced my native lens.This lens was also supposed to flex, so i could see near and far; that never happened.I have only ever had distant vision with that eye.My right eye has now been diagnosed with a cataract at (b)(6).My vision has slowly been clouding in that eye, so it's probably been going on for a year or so.I am in the process of seeking a repeat surgery to correct the right eye.I had also been told that dr (b)(6) no longer does eye surgery on younger pts.And, he doesn't or maybe isn't even allowed to work in (b)(6).Also, (b)(6) no longer follows pts with intraocular lens implants necessitating seeking f/u treatment elsewhere.

• Brand Name: STAAR SURGICAL MICL 12.6
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY
• MDR Report Key: 8176090
• MDR Text Key: 131025230
• Report Number: MW5082245
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/15/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Weight: 73