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 Problems Visual Impairment (2138); No Code Available (3191)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

The device has not been returned for evaluation.A review of the device history record did not show any anomalies or nonconformities that would have contributed to the reported event.A follow-up report will be submitted upon completion of investigation.

Event Description

A user facility reported that a patient described poor vision of the right eye one day post intraocular lens (iol) implant of the right eye.The iol was removed and replaced with the same model and different diopter lens approximately three-months post implant due to a mispositioned nasal haptic which caused a change in the lens orientation.The original procedure was phacoemulsification only and was not complicated in any way.The reporter did not indicate the reason why the lens/haptic could not be properly positioned in the bag, however, indicated that it was not related to patient anatomical issues and that the haptic was not bent by the inserter.Though requested, the inserter used to implant the lens was not reported.The patient's current prognosis is good.Though requested, no additional information was provided.

Manufacturer Narrative

Iol was retuned for evaluation.Visual inspection found the lens was in two pieces.One plate was torn off and missing; the other plate remained attached to the larger half of the returned piece of optic.The haptic arms were attached to the plate and the arms were not damaged.The other plate was torn at one haptic junction.The cause of the damage could not be determined.There have been no other similar events reported for this lot to date.The device history record (dhr) review, did not find any anomalies or non-conformities related to this event.The lot history, trend analysis, risk analysis and directions for use review are considered acceptable, with the product performing within anticipated rates.Based on the information provided, the root cause of this event could not be conclusively determined.No further actions are deemed necessary at this time.

• Brand Name: CRYSTALENS ACCOMMODATING IOL
• Type of Device: LENS, INTRAOCULAR, ACCOMMODATIVE
• Manufacturer (Section D): BAUSCH + LOMB; 1400 n. goodman; rochester NY 14609
• MDR Report Key: 11047449
• MDR Text Key: 222709035
• Report Number: 0001313525-2020-00205
• 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: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: AO1UV
• Device Catalogue Number: AO1UV-2200
• Device Lot Number: 7653007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR