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

Model Number MXUT

Device Problem Break (1069)

Patient Problem Eye Injury (1845)

Event Date 07/11/2019

Event Type  Injury  

Manufacturer Narrative

Lens associated with this event was requested, but has not been returned for evaluation.A review of nonconformances (ncs) from three years prior to event date was performed.There were no ncs that would contribute to the reported complaint issue.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.The most probable root cause is "operational context".User related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have contributed to the event.No corrective action is necessary at this time.A supplement report will be submitted if the sample is returned for evaluation.

Event Description

The intraocular lens (iol) was implanted into the patient¿s left eye and removed intraoperatively due to a damaged haptic.There was an incision enlargement and sutures were required.The trailing haptic of the toric iol was noted to be fully broken off after insertion into eye.The lens was exchanged for a different model of the same diopter.No further complications occurred: the iol optic was clear and free of debris and the orientation of the lens did not change.In the surgeon¿s opinion, the likely cause of the event was a broken haptic which was likely iatrogenic.The patient did not notice a decrease in their vision.Standard post-op vision has been reported to date.The patient will need suture removal, but overall normal post-op good prognosis is expected.

Manufacturer Narrative

The lens associated with this event was requested, but has not been returned for evaluation.Lot and serial number information was obtained.The lot history was review was considered acceptable, with the product performing within anticipated rates.All original conclusions remain unchanged.No corrective action is necessary at this time.A supplement report will be submitted if the sample is returned for evaluation.

• Brand Name: ENVISTA TORIC INTRAOCULAR LENS
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 8890744
• MDR Text Key: 154414489
• Report Number: 0001313525-2019-00120
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: MXUT
• Device Catalogue Number: MXUT350+115
• Device Lot Number: 3941218
• Was Device Available for Evaluation?: No
• 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: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLIS-X1 INJECTOR 0001313525-2019-00121; BLIS-X1 INJECTOR 0001313525-2019-00121
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR