MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA TORIC INTRAOCULAR LENS; LENS, INTRAOCULAR, TORIC OPTICS

Model Number MXUET

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 12/03/2020

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.

Event Description

Reportedly, patient could feel the lens in the eye after it was implanted.Upon consult, the lens was explanted.In the surgeon's opinion the lens may have slightly tilted in the bag.Additional information has been requested and not received.

Manufacturer Narrative

Although requested, additional information was not received.And the device was not returned for evaluation.A review of the device history record (dhr) did not find any anomalies or non-conformities related to this event.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.There have been no other related complaints for this lot to date.Based on the available information, the root cause of this event could not be conclusively determined.No corrective action is required at this time.

• Brand Name: ENVISTA TORIC INTRAOCULAR LENS
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman st.; rochester NY 14609
• MDR Report Key: 11158976
• MDR Text Key: 226578107
• Report Number: 0001313525-2021-00007
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): Y
• PMA/PMN Number: P910056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/31/2023
• Device Model Number: MXUET
• Device Catalogue Number: MXUET125+200
• Device Lot Number: 3044223
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention