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 07/10/2019

Event Type  Injury  

Manufacturer Narrative

The lens associated with this event was not available to be returned for evaluation.The lot history, trend analysis, risk analysis and directions for use review are 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.Incision was enlarged to remove the iol, sutures placed as part of standard protocol.The capsular bag was not damaged, and there was no loss of vitreous fluid and no vitrectomy was performed.The lens was exchanged with the same model lens with a different diopter.In the physician''s opinion, the likely cause of the event was that the haptic was cut.Patient reported to be doing well with no additional incidents.

• 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
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: tes proud ; 1400 north goodman street; rochester, NY 14609 ; 5853388549
• MDR Report Key: 8897433
• MDR Text Key: 154435962
• Report Number: 0001313525-2019-00122
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P910056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,07/18/2019

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: 01/31/2022
• Device Model Number: MXUT
• Device Catalogue Number: MXUT200+210
• Device Lot Number: 3944119
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BLIS-X1 INJECTOR - MDR 0001313525-2019-00123
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR