MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number MX60E

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 11/18/2020

Event Type  Injury  

Manufacturer Narrative

The product has not been returned for evaluation.Though requested, no further information has been provided by the reporting facility.The investigation is on-going.

Event Description

It was reported that approximately 3 months after intraocular lens (iol) implantation surgery, the lens was explanted due to dislocation and exchanged with a different model and diopter lens.Additional information has been requested from the reporter, but has not been received.

Manufacturer Narrative

Additional information received indicating patient had pre-existing conditions; therefore, this event was reassessed as not related to the device and is no longer reportable.

• 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: 11008928
• MDR Text Key: 221515106
• Report Number: 0001313525-2020-00195
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

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: 05/31/2023
• Device Model Number: MX60E
• Device Catalogue Number: MXUE1850
• Device Lot Number: 3054604
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention