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

Model Number LI61AO

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/17/2022

Event Type  Injury  

Manufacturer Narrative

Device has been returned for evaluation.Visual inspection found the device was cut or torn into two pieces.Both haptics were bent.Due to the damage, the cause of damage could not be determined.The lot history, trend analysis, risk analysis and/or directions for use review were 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.

Event Description

It was reported that after insertion of an iol into the right eye, two bent haptics were observed.The incision was enlarged to remove the lens and another iol of the same model and diopter was implanted.

• Brand Name: SOFPORT AO INTRAOCULAR LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 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, FL 33759 ; 7277246600
• MDR Report Key: 15790292
• MDR Text Key: 303579190
• Report Number: 0001313525-2022-00165
• 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: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: LI61AOR1750
• Device Lot Number: 4259502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2022
• 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
• Treatment: EZ-28V INSERTER
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male