MAUDE Adverse Event Report: NOVARTIS / ALCON TORIC LENS

Device Problems Improper or Incorrect Procedure or Method (2017); Material Integrity Problem (2978)

Patient Problems Cataract (1766); Vitreous Floaters (1866); Visual Impairment (2138); Complaint, Ill-Defined (2331)

Event Date 05/02/2016

Event Type  Injury  

Event Description

I had lasik surgery with mono-vision (distance in one eye, close-up in the other) in (b)(6) 2005.I was (b)(6).Less than 10 years later, i was diagnosed with cataracts.The clinic that performed my lasik surgery, recommended i have cataract surgery in 2016.As i did not want to wear glasses after surgery, it was suggested i have a laser assisted cataract surgery with a toric lens.Surgery was performed on my "distance" eye on (b)(6) 2016.Six weeks after surgery, it was determined my vision was not appropriately corrected.Rather than achieving clear distance vision, the correction resulted in a "refractive surprise", giving my dominant eye vision for reading.A second surgery was planned, in which the vision would be corrected by either a piggy back iol or prk; however, before the surgery could take place, posterior capsule opacification occurred, which resulted in yag surgery.(i still have floaters which occasionally cloud my vision.) at no time was i told: the use of steroid drops after lasik could result in early onset cataracts; that the calculation of the intraocular lens power for cataract surgery is inaccurate after lasik; that following lasik poor vision may result post cataract surgery; that there may be an increased risk of repeat surgeries.Rather, the doctor assured me the more expensive laser assisted surgery and toric lens was my best bet for clear vision without glasses, and that he could "tweek" my vision if necessary.(the literature regarding the toric lens does not adequately address its use post lasik surgery.) the surgeon now wants to perform a third surgery, prk.A list of potential risks and side effects of prk were only given to me shortly before the scheduled surgery.There was never any mention of or discussion about the increased risks of prk following lasik/cataract surgery.After researching the risks associated with having prk after lasik, i have decided to foreign surgery and just wear glasses.

• Brand Name: TORIC LENS
• Type of Device: TORIC LENS
• Manufacturer (Section D): NOVARTIS / ALCON
• MDR Report Key: 5865388
• MDR Text Key: 51849577
• Report Number: MW5063968
• Device Sequence Number: 1
• Product Code: LPL
• 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: 08/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 59