MAUDE Adverse Event Report: BAUSCH + LOMB SOFPORT AO INTRAOCULAR LENS

Model Number LI61AO

Device Problems Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/15/2021

Event Type  Injury  

Event Description

It was reported that the intraocular lens (iol) was implanted in the right eye and removed due to an unknown iol damage.Lens were removed through an enlarged incision and no sutures were required.Additional information has been requested, but not received.

Manufacturer Narrative

The device was returned for evaluation.Visual inspection found a scratch in the middle of the lens and both haptics were bent.The device history record (dhr) was reviewed, and there were no discrepancies or deviations found related to the reported issue.The trend analysis, risk analysis, and directions for use review are considered acceptable, with the product performing within anticipated rates.Based on the available information, user-related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have caused or contributed to the event.

• Brand Name: SOFPORT AO INTRAOCULAR LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; 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
• MDR Report Key: 13018509
• MDR Text Key: 282336854
• Report Number: 0001313525-2021-00157
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910061
• 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
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LI61AO
• Device Catalogue Number: LI61AOR2000
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EZ 28V DELIVERY DEVICE
• Patient Outcome(s): Required Intervention