MAUDE Adverse Event Report: BAUSCH + LOMB L122UV ANTERIOR CHAMBER PMMA LENS; INTRAOCULAR LENS

Model Number 8U200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Edema (1791); Blurred Vision (2137)

Event Date 08/01/2022

Event Type  Injury  

Event Description

It was reported that a patient presented with a decrease in vision approximately 10 years and 3 months after the implantation of an anterior chamber (ac) intraocular lens (iol) into the right (od) eye due to a decompensating cornea and corneal edema.A successful lens exchange was completed using a different model iol.In the surgeon's opinion, the most likely cause of the event was the anterior chamber (ac) iol induced corneal decompensation.

Manufacturer Narrative

The device was returned for evaluation.Visual inspection found the device was in a dried condition, but not damaged and no defects were observed.A review of the device history record (dhr) did not find any non-conformities or anomalies related to the event.Investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.

Manufacturer Narrative

The lot history, trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.Based on the available information, a root cause of the event could not be conclusively determined.

• Brand Name: L122UV ANTERIOR CHAMBER PMMA LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman st; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 15341159
• MDR Text Key: 299147960
• Report Number: 0001313525-2022-00110
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2013
• Device Model Number: 8U200
• Device Catalogue Number: L122UV
• Device Lot Number: 2828503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2022
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male