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

Model Number MX60ET

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2021

Event Type  Injury  

Manufacturer Narrative

The lens was returned for evaluation.Visual inspection found the lens cut or torn, with one haptic attached to the optic and the other haptic is missing.The device history record (dhr) was reviewed, and there were no discrepancies or anomalies related to the reported issue.The trend analysis, risk analysis, and directions for use review are 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

It was reported the intraocular lens (iol) was implanted into the patient¿s right eye (od) and was found to have a sheared haptic.It was unclear if this happened during loading of the iol or implant.Incision was enlarged to remove the lens with the use of lens cutters.Another lens of the same model and diopter was successfully implanted.Sutures were required to close.

Manufacturer Narrative

Previous assessment and conclusion has not changed and remains the same.

Event Description

Additional information regarding patient¿s visual acuity on the right eye was received indicating patient had a good outcome.

• 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: 12373714
• MDR Text Key: 268341703
• Report Number: 0001313525-2021-00111
• 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: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: MX60ET
• Device Catalogue Number: MXUET350+245
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BAUSCH AND LOMB INJECTOR SYSTEM (BLIS).; BAUSCH AND LOMB INJECTOR SYSTEM (BLIS)
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR