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 10/29/2019

Event Type  Injury  

Manufacturer Narrative

The reporter has indicated the lens is not available for return as it remains implanted.Additional information has been requested, but has not been received.The investigation is in progress.A follow-up report will be submitted as additional information is received.

Event Description

A surgeon reported that a patient underwent a yytrium aluminum garnet (yag) laser treatment for z syndrome of the intraocular lens (iol).The treatment was not effective in resolving the patient¿s z syndrome.The surgeon is considering performing another yag treatment on the lens three months after the initial yag.The surgeon does not plan to remove the lens.Additional information has been requested, but has not been received.

Manufacturer Narrative

Additional information has been requested from the account, but has not been received.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.

• Brand Name: CRYSTALENS ACCOMMODATING IOL
• Type of Device: LENS, INTRAOCULAR, ACCOMMODATIVE
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 9653694
• MDR Text Key: 177267363
• Report Number: 0001313525-2020-00017
• Device Sequence Number: 1
• Product Code: NAA
• Combination Product (y/n): Y
• PMA/PMN Number: P030002
• 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: 01/01/2005,01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: AO1UV
• Device Catalogue Number: AO1UV-2250
• Device Lot Number: 7654514
• 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: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention