MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number MXUE

Device Problems Material Opacification (1426); Particulates (1451)

Patient Problems Eye Injury (1845); Visual Impairment (2138)

Event Date 04/08/2019

Event Type  Injury  

Manufacturer Narrative

The investigation of this event is in progress.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

It was reported that the surgeon noticed what appeared to be central granular opacity in the visual axis below the iol surface, which resulted in an explant of the lens.A lens exchange with the same model and diopter was performed.

Manufacturer Narrative

Correction to the reportability awareness date was 14 may 2019.The lens was returned for evaluation.The optic has been cut or torn in half.Microscopic examination found loose particulates on the optic, however, embedded particulates are not present on the optic.Visual inspection found some large and small areas on the optic that are cloudy white in appearance.In addition, there are raised areas that have the appearance of particles or substances that do not wipe off.The microscopy performed did not reveal central granular opacity, as these areas seemed to be concentrated in the outer half of the lens rather than the center.There were a few unspecific deposits of what appeared to be dry ophthalmic viscosurgical device (ovd), as well as a relatively large piece of a dark deposit close to the bisection site.The dark deposit did not appear to be a piece of ocular tissue, but a contaminant which detached from the surface of the lens after hydration in distilled water at body temperature for 24 hours.Attachment of this material to the iol surface may have occurred during manipulation of the lens after explantation.In the dry state or after full hydration no central granular opacity was observed.The investigation of this event is in progress.A follow up report will be submitted upon completion of the investigation.

Event Description

The patient did experience a decrease in vision, but the patient's prognosis is excellent and post-op vision was at target with excellent acuity.

Manufacturer Narrative

Additional product evaluation was performed.Central granular opacity was not observed.There were no deposits on or within the lens looking like calcification; there were no glistenings or subsurface nanoglistenings.The product evaluation did not confirm the failure mode.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.A root cause for the reported event could not be conclusively determined.Due to evidence of use / handling, the most probable root cause is operational context.No corrective action is necessary at this time.The investigation is complete.

• Brand Name: ENVISTA INTRAOCULAR LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman st; rochester NY 14609
• MDR Report Key: 8693805
• MDR Text Key: 147857416
• Report Number: 0001313525-2019-00095
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): Y
• PMA/PMN Number: P080021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: MXUE
• Device Catalogue Number: MXUE2200
• Device Lot Number: 3771709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR