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

Model Number MX60UT

Device Problems Material Opacification (1426); Material Integrity Problem (2978)

Patient Problem Visual Impairment (2138)

Event Date 10/18/2018

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is in progress.A follow-up report will be submitted upon completion of the investigation.

Event Description

The surgeon is reporting that glistening and/or cloudiness was observed on an implanted lens one day post-surgery.The lens was implanted in the patient's left eye.Reportedly, the surgeon also noted a lathing pattern on the lens.Initially, there were no visual disturbances (patient's vision was measured as j1 with no blurriness).At the one week post-op mark, however, the patient's vision had decreased to 20/50.As a result, the lens was explanted and replaced with another toric lens of a different model.The replacement lens had the same diopter power as the initial lens, but slightly less cylindrical power.The surgeon attributes the decreased vision to the lens.Following the lens exchange, the patient is said to be much better.The patient's vision was measured as j1 once more.

Manufacturer Narrative

The explanted lens was evaluated by an outside specialist contracted by b+l.On the surface of the lens, deposits appearing to correspond to dried balanced salt solution material and protein deposition were observed.Furthermore, manufacturing lathe lines were observed under light microscopy.No glistening, sub-surface nano-glistening, or evidence of lens opacification was observed during analytical testing.A device history record (dhr) review did not find any nonconformities or anomalies related to this complaint.Based on the available information, a root cause for the reported event could not be conclusively determined.It should be noted that actions were initiated at the manufacturing site to investigate the device manufacturing process.

• 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: 8066728
• MDR Text Key: 127053475
• Report Number: 0001313525-2018-00206
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: MX60UT
• Device Catalogue Number: MXUT2250200
• Device Lot Number: 3858726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR