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

Model Number MX60T

Device Problem Insufficient Information (3190)

Patient Problem Halo (2227)

Event Date 10/08/2020

Event Type  Injury  

Manufacturer Narrative

The lens was returned for evaluation in a plastic specimen cup in a fluid.The part number and serial number could not be verified; however, the lens does have the appearance of the reported lens.Particulates and scratches appeared to be visible on the lens.There was an area on the optic that was cloudy white and had an uneven surface with a frost like pattern.Visual inspection found the lens was cut or torn in half and one haptic was attached to each piece of the optic.One haptic was torn at the loop next to the optic.Due to the device condition, functional and diopter testing could not be performed.A review of the device history record has been performed and there were no anomalies or discrepancies identified that may have contributed to the reported event.A review of non-conformances did not identify any inconsistencies that would contribute to the reported event.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.The investigation is ongoing.

Event Description

It was reported, one day post operation of a non-complicated phacoemulsification surgery to implant an intraocular lens in the left eye the patient experienced decreased vision due to glare.On slit lamp examination a 1.5mm central clear area was seen surrounded by sub surface refractive particles.The orientation of the lens did not change.Approximately one month after iol implant, the lens was removed and replaced with a lens of a same model and diopter.The patient's current prognosis is good.In the surgeon¿s opinion the most likely cause of the event was a defective iol.

Manufacturer Narrative

The iol was returned to b+l for investigation.Upon further analysis through optical inspection, laser confocal microscopy, and slit lamp microscopy, the explanted lens did not exhibit machine marks or unacceptable lathe lines and no other evidence of defects or surface contamination was observed.Based on the results of this evaluation, the root cause of this event could not be determined.

• 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: 11010514
• MDR Text Key: 221513723
• Report Number: 0001313525-2020-00196
• 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: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: MX60T
• Device Catalogue Number: MXUET200+205
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMVISC, BLIS INJECTION SYSTEM; AMVISC, BLIS INJECTION SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR