MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number MX60E

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2018

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

It was reported that the surgeon noticed a scratch on the lens after insertion into the patient's right eye.The scratch appeared to be in the lens and not on the surface of the lens.The incision was enlarged to remove the lens and sutures were used to seal the incision.A backup lens was said to be successfully implanted.The current patient prognosis is good.

Manufacturer Narrative

Additional information: the device was returned for evaluation.The lens was in the vial, which was inside a plastic specimen cup.The lens was in a wet condition.Particulates were visible on the optic.Visual inspection found the lens is in two pieces.The optic was cut or torn in half.The lens was rinsed in processed water and then microscopically examined.No scratches were found.The device history record (dhr) was reviewed and there were no discrepancies or anomalies that relate to the reported issue.Based on the information available, the root cause of the reported event could not be conclusively determined.

• Brand Name: ENVISTA INTRAOCULAR LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 8261613
• MDR Text Key: 133559714
• Report Number: 0001313525-2019-00023
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): Y
• PMA/PMN Number: P910056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: MX60E
• Device Catalogue Number: MXUE1950
• Device Lot Number: 3867215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLIS-X1 BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE; BLIS-X1 BAUSCH + LOMB INJECTOR SYSTEM CARTRIDGE
• Patient Outcome(s): Other
• Patient Age: 75 YR