MAUDE Adverse Event Report: BAUSCH + LOMB CRYSTALENS ACCOMMODATING IOL; LENS, INTRAOCULAR, ACCOMMODATIVE

Model Number AO1UV

Device Problems Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981)

Patient Problem No Code Available (3191)

Event Date 02/25/2020

Event Type  Injury  

Manufacturer Narrative

The intraocular lens (iol) was returned in a plastic specimen cup.The original packaging was not returned, however, the reported lens identification information was written on the label.The lens was in two pieces, as the optic had been cut or torn in half.Three haptic arms were torn off and missing.The fourth haptic arm was bent.Functional testing cannot be performed due to the damage.The cause of the damage cannot be determined.The device history record (dhr) was reviewed and there were no discrepancies or deviations found that related to the reported issue.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 that this event is patient-related.In the surgeon¿s opinion, the most likely cause of the event was asymmetrical posterior capsule contraction causing z-tilt of optic.No corrective action is necessary at this time.

Event Description

It was reported that approximately six weeks post implant of an intraocular lens (iol) in the left eye (os), that the patient developed z- optic tilt.The patient noticed a decrease in their vision.Iol repositioning / rotation was successfully performed three days post event, but z tilt reoccurred approximately three weeks later.An iol explant and replacement was successfully performed four and half months post original implant using an iol of a different model, but the same diopter.There were no complications with the original surgery.The iol optic was free and clear of any debris.In the physician¿s opinion the most likely cause was asymmetrical posterior capsule contraction causing z-tilt of optic.The patient current prognosis is recovering from iol exchange.Patient prognosis is good.

• Brand Name: CRYSTALENS ACCOMMODATING IOL
• Type of Device: LENS, INTRAOCULAR, ACCOMMODATIVE
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer Contact: stephanie anastasiou ; 21 north park place blvd; clearwater, FL 33759 ; 7277246659
• MDR Report Key: 9885472
• MDR Text Key: 188207914
• Report Number: 0001313525-2020-00063
• Device Sequence Number: 1
• Product Code: NAA
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P030002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: AO1UV
• Device Catalogue Number: AO1UV-2100
• Device Lot Number: 7643510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• 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
• Date Manufacturer Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR