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

Model Number MX60TP

Device Problems Material Twisted/Bent (2981); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Vitreous Loss (2142); Capsular Bag Tear (2639); Vitrectomy (2643); No Code Available (3191)

Event Date 10/08/2019

Event Type  Injury  

Manufacturer Narrative

The product has been returned and is pending evaluation.The investigation is ongoing.

Event Description

It was reported that during the insertion of an intraocular lens (iol) there was a lens folding issue with the leading haptic.The incision was enlarged to remove the lens intraoperatively, and sutures were required.Though requested, no additional information has been received.

Manufacturer Narrative

The product evaluation has been completed.One opened lens box was returned complete with all components.The lens was in a dried condition inside the vial.Particulates, saline dentrites and dried solutions were visible on the optic.Visual inspection found one haptic bent.The delivery device was not returned.The cause of the damage cannot be determined.Functional testing cannot be performed using a delivery device due to the damaged.However, after re-hydrating the lens, the lens folded easily using folding forceps.The product evaluation could not verify the failure mode.No similar complaints have been received for this product lot.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.Based on the information provided, we are unable to determine a root cause.No corrective action is necessary at this time.

Event Description

The capsular bag was damaged in the right eye, and there was a loss of vitreous.A vitrectomy was performed and the incision was enlarged to remove the intraocular lens (iol).Sutures were used.The iol damage was noticed intraoperatively.The plan of surgery was changed to 3 piece iol, and the second iol was implanted successfully.In the physician¿s opinion, the most likely cause of the iol damage was lens stuck in delivery device.Good patient prognosis.

• Brand Name: ENVISTA TORIC INTRAOCULAR LENS
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n. goodman; rochester NY 14609
• MDR Report Key: 9707619
• MDR Text Key: 183718426
• Report Number: 0001313525-2020-00032
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: MX60TP
• Device Catalogue Number: MX60TP575+250
• Device Lot Number: 3849223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2020
• 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: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLIS INSERTER
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR