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

Model Number MX60TP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Capsular Bag Tear (2639)

Event Date 11/14/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the capsular bag broke during insertion of the lens into the left eye.As a result, the lens was cut out and removed by the surgeon.The patient was left without a lens at the end of the procedure.Upon follow-up examination, the patient's eye was stated to be doing well.The patient has been referred to another surgeon for a second attempt at implanting a lens.

Manufacturer Narrative

The lens was not available for return.A device history record (dhr) review did not find any nonconformities or anomalies related to this complaint.Based on the available information, a root cause for the reported event could not be conclusively determined.However, it should be noted that the delivery device used during surgery was not validated for use with the lens and cartridge.

• Brand Name: ENVISTA TORIC INTRAOCULAR LENS
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 8188121
• MDR Text Key: 131144216
• Report Number: 0001313525-2018-00245
• 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: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2018

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: 11/30/2020
• Device Model Number: MX60TP
• Device Catalogue Number: MX60TP425+160
• Device Lot Number: 3774004
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/25/2019; 04/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other