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

Model Number MXUT

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Capsular Bag Tear (2639); Vitrectomy (2643)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

The product is not available for analysis.Investigation is under way.

Event Description

It was reported that a patient¿s posterior capsule was broken during implantation of an intraocular lens (iol).The iol was cut up for removal intraoperatively.The lens was exchanged for a lens of a different model and diopter.A vitrectomy was performed.The reporter is unsure why or how the capsule damage occurred, but states that there are no product quality concerns.The reporter does not have any information about the patient's current status.Though requested, no additional information was provided.

Manufacturer Narrative

Though requested, no additional information has been provided.According to the reporter, the lens is not available for evaluation.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.Based on the information provided, we are unable to determine a root cause.No corrective action is necessary at this time.

• Brand Name: ENVISTA TORIC INTRAOCULAR LENS
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n goodman; rochester NY 14609
• MDR Report Key: 9507237
• MDR Text Key: 182779536
• Report Number: 0001313525-2019-00217
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: MXUT
• Device Catalogue Number: MXUT275+275
• Device Lot Number: 3874977
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NUVISC, BLIS INSERTER
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR