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

Model Number MXUT

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Visual Impairment (2138); Capsular Bag Tear (2639); No Code Available (3191)

Event Date 12/19/2019

Event Type  Injury  

Manufacturer Narrative

The product has not been returned for evaluation.Additional information has been requested, but has not been received.The investigation is on-going.A follow up report will be submitted once additional information is received.

Event Description

It was reported the intraocular lens (iol) dislocated inferiorly and the surgeon had to perform an iol exchange twenty days post original surgery with a different model lens in the sulcus.Additional information has been requested, but has not been received.

Manufacturer Narrative

The intraocular lens (iol) was returned for evaluation in a small plastic specimen cup with one lens label affixed to the outside.The lens was in an unknown fluid.Particulates were visible on the optic.Visual inspection found the lens was in two pieces.The optic had been cut or torn in half.One haptic is attached to each piece of the optic.A small chunk of the optic was torn off near one haptic and that chunk was missing.The cause of the damage cannot be determined.Functional testing cannot be performed due to the damage.The device history record (dhr) was reviewed and there were no discrepancies or deviations found that related to the reported issue.There have been no other complaints on this lot date.The lot history, trend analysis, risk analysis, and directions for use 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

Additional information provided by the surgeon reported the toric intraocular lens (iol) tore an opening in the posterior capsular bag while being implanted into the capsular bag of the right eye.The surgery was not combined with any other surgery.The optic was free and clear of imperfections.One day post implant, the patient noticed a decrease in their vision.In the surgeon''s opinion, the likely cause of the event was the dislocation of the iol.The patient''s prognosis is stable and good, but will need glasses to correct astigmatism.

• 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: 9660760
• MDR Text Key: 183011484
• Report Number: 0001313525-2020-00022
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• 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+160
• Device Lot Number: 3944118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• 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: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMVISC PLUS VISCOELASTIC
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR