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

Model Number MXUT

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Code Available (3191)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

Per the reporting facility, the device is not available for return.No device evaluation can be performed.The investigation is ongoing.

Event Description

It was reported that during a phacoemulsification surgery to implant an intraocular lens (iol) into the right (od) eye, the haptic tore after implant.The surgeon enlarged the original incision of 2.4mm to 4.4mm and performed a successful intraoperative lens exchange using a back up lens of the same model, but different diopter.10-0 nylon sutures were used.In the surgeon''s opinion, the lens was torn at the back haptic as it was being delivered through the injector cartridge.The patient did not notice a decrease in vision and is doing well, but there is residual cylinder.The patient's outcome is good.

Manufacturer Narrative

The device history record (dhr) was reviewed and there were no discrepancies or deviations found that related to the reported issue.The lot history, trend analysis, risk analysis, and directions for use are considered acceptable with the product performing within anticipated rates.The most probable root cause is user related.User related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have contributed to the event.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 north goodman street; rochester NY 14609
• MDR Report Key: 11122910
• MDR Text Key: 225273280
• Report Number: 0001313525-2021-00001
• 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: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: MXUT
• Device Catalogue Number: MXUT200+095
• Device Lot Number: 3955105
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLIS INJECTOR, AMVISC VISCOELASTIC; BLIS INJECTOR, AMVISC VISCOELASTIC
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR