MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number MX60E

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 12/22/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation.The investigation is on-going.

Event Description

It was reported an intraocular lens (iol) was explanted from the left (os) eye approximately one month after implant due to dislocation of the iol.A successful lens exchange using a different model lens was performed, however, the surgery was complicated as the replacement lens was an anterior chamber iol.There was no incision enlargement, but the surgeon used 10-0 monosoft sutures.In the surgeon's opinion, the most likely cause of the event was dislocation of the iol and the patient's outcome is reported to be good.

Manufacturer Narrative

The product was returned and evaluated.Visual inspection found the intraocular lens (iol) cut in half.The haptics were bent and one haptic was torn at the base.Functional testing could not be preformed due to the damage and cause of the damage could not be determined.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.Based on the information provided, we are unable to determine a root cause.

• 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: 11253478
• MDR Text Key: 229576626
• Report Number: 0001313525-2021-00018
• 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,health profession
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: MX60E
• Device Catalogue Number: MXUE0800
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLIS INJECTOR, PROVISC VISCOELASTIC
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR