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

Model Number MXUT

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

Patient Problem Eye Injury (1845)

Event Date 06/10/2019

Event Type  Injury  

Manufacturer Narrative

The lens associated with this event was requested, but has not been returned for evaluation.Despite multiple requests, no additional information has been received.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.There have been no other complaints reported for this lot to date.Based on the information provided, we are unable to determine a root cause.No corrective action is necessary at this time.A supplement report will be submitted if additional information is received, or the sample is returned for evaluation.

Event Description

It was reported that the lens was explanted.Though requested, no further information has been provided.

• 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
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: tes proud ; 1400 north goodman street; rochester, NY 14609 ; 5853388549
• MDR Report Key: 8898096
• MDR Text Key: 154459521
• Report Number: 0001313525-2019-00124
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P910056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/01/2005,07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: MXUT
• Device Catalogue Number: MXUT350+185
• Device Lot Number: 3949805
• 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: 07/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention