MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number MX60P

Device Problem Scratched Material (3020)

Patient Problem Unspecified Eye / Vision Problem (4471)

Event Date 02/23/2021

Event Type  Injury  

Manufacturer Narrative

Though requested from the reporter, the device was not returned for evaluation.The device history record (dhr) was reviewed and there were no discrepancies or deviations found that related to the reported issue.The lot history, trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.The most probable root cause is operational context.User related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have contributed to the event.On (b)(6) 2021, bausch + lomb received an email from (b)(6) at cdrh/food and drug administration notifying the company that the report initially submitted on (b)(6) 2021 failed in the emdr system with an error due to the presence of the ¿}¿ character as part of the c-code value.There was no ack3 error message which notifies the company that the submission was rejected due to the character.The special character (¿}¿) has been removed and this report is being resubmitted.

Event Description

It was reported after an intraocular lens (iol) was implanted into the right (od) eye, the surgeon noticed a scratch at the center of the optic.The incision was enlarged to 3.0mm to explant the iol.A back up iol of the same model and diopter power was successfully implanted intraoperatively.Two sutures were used.The patient did not notice a decrease in vision.In the surgeon's opinion, the most likely cause of the event is due to folding/unfolding of the lens, however the surgeon indicated there was no difficulty in loading or injecting the lens.The patient's outcome is good.

Manufacturer Narrative

The product was returned for evaluation.The lens was in a dried condition.Particulates, saline dendrites and dried solutions were visible on the optic.Visual inspection found the lens was cut or torn into two pieces.One haptic was attached to each piece of the optic.Microscopic examination was performed and found a scratch across the optic.The cause of the damage could not be determined.Functional testing could not be performed due to the damage.Our previous conclusions remain unchanged.

• Brand Name: ENVISTA INTRAOCULAR LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 11592437
• MDR Text Key: 243128787
• Report Number: 0001313525-2021-00043
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): Y
• PMA/PMN Number: P910056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

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 Expiration Date: 02/28/2023
• Device Model Number: MX60P
• Device Catalogue Number: MX60P1300
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/30/2021
• Supplement Dates Manufacturer Received: 05/03/2021
• Supplement Dates FDA Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLIS INJECTOR, AMVISC PLUS VISCOELASTIC
• Patient Outcome(s): Required Intervention