MAUDE Adverse Event Report: BAUSCH & LOMB ENVISTA INTRAOCULAR LENS

Model Number MX60E

Device Problem Break (1069)

Patient Problems Visual Impairment (2138); Vitrectomy (2643); No Code Available (3191)

Event Date 01/06/2021

Event Type  Injury  

Manufacturer Narrative

Even though requested, the device was not returned for evaluation as it was discarded.The device history record (dhr) review, did not find any non-conformities or anomalies related to the reported event.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Reportedly, a forceps was used to implant this device.According to the dfu, the use of an approved delivery device is recommended and therefore, the most likely root cause of this event is user related.

Event Description

Reportedly, an intraocular lens was implanted by a forceps.Approximately four months post-op, patient noticed a decrease in their vision.Due to a broken haptic-eyelet junction, the lens had post-operatively dislocated.Lens was explanted and replaced with a different model lens.Vitrectomy was performed and sutures were required.The patient's current outcome is good.

Manufacturer Narrative

Correction: the incorrect manufacturer registration number (3011423170) in the mdr numbering was used.The correct manufacturer registration number corresponding to this device is 1313525.

• 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: 11374466
• MDR Text Key: 241673578
• Report Number: 3011423170-2021-00026
• 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: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: MX60E
• Device Catalogue Number: MXUE2100
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN FORCEPS
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR