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

Model Number MX60PT

Device Problem Scratched Material (3020)

Patient Problem Insufficient Information (4580)

Event Date 07/14/2022

Event Type  Injury  

Manufacturer Narrative

Although requested, the device was not returned for evaluation.A review of the device history record did not identify any anomalies or nonconformities that could be related to this event.The investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.

Event Description

Reportedly, an implanted lens was discovered to have a scratch on the optic during a postop visit.The lens was explanted and exchanged with an unknown lens five days postop.Additional information has been requested.

Manufacturer Narrative

Device was returned and evaluated.Device evaluation found scratches on the optic.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, user-related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have caused or contributed to the event.

Event Description

The left lens was exchanged for a lens of the same model and diopter.

• 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: shayan habibi ; 7277246600
• MDR Report Key: 15209615
• MDR Text Key: 297693915
• Report Number: 0001313525-2022-00102
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: MX60PT
• Device Catalogue Number: MXUPT275+190
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENVISTA SIMPLIFEYE INSERTER
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male