MAUDE Adverse Event Report: BAUSCH + LOMB SURGICAL CRYSTALENS INTRAOCULAR LENS; LENS,INTRAOCULAR, ACCOMMODATIVE

Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problems Complaint, Ill-Defined (2331); Zonular Dehiscence (2698); Fibrosis (3167)

Event Type  Injury  

Event Description

It was reported that a post-lasik patient was doing well with ucva 20/20, but after a few weeks noted negative dysphotopsia.The surgeon noticed capsular fibrosis and a small amount of zonular laxity/dialysis near the superior haptic.The surgeon waited about 6-8 weeks, but symptoms did not improve.The surgeon then rotated the lens and placed a ctr to hold lens in position.At day one, the dysphotopsia totally resolved.But at one week, the lens vaulted.The surgeon is evaluating treatment options.Additional information has been requested.

Manufacturer Narrative

Investigation is underway.A supplemental report will be submitted upon completion of the investigation.

• Brand Name: CRYSTALENS INTRAOCULAR LENS
• Type of Device: LENS,INTRAOCULAR, ACCOMMODATIVE
• Manufacturer (Section D): BAUSCH + LOMB SURGICAL; rancho cucamonga CA
• Manufacturer Contact: sharon spencer; bausch + lomb ; 50 technology drive; irvine, CA 92618 ; 9493985698
• MDR Report Key: 4169517
• MDR Text Key: 5021271
• Report Number: 2031924-2014-00261
• Device Sequence Number: 1
• Product Code: NAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other