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

Model Number AO1UV

Device Problem Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/11/2018

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is in progress.A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported that a crack in the lens was noticed after it was inserted into the patient's right eye.Allegedly, the trailing haptic was ripped by the inserter.Sutures were required and the incision was enlarged.The lens was removed and replaced with the same model and diopter back-up.

Manufacturer Narrative

The lens was returned to b+l.Visual inspection found one set of haptic arms and a small portion of the plate torn off and missing.The other plate with arms and the optic are not damaged.The cause of the damage cannot be determined.Due to the damage, functional testing cannot be performed.The device history record (dhr) was reviewed and there were no discrepancies or unusual findings that relate to the reported issue.Based on the current information, the root cause of the event could not be conclusively determined.However, it is possible that 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.

• Brand Name: CRYSTALENS ACCOMMODATING IOL
• Type of Device: LENS, INTRAOCULAR, ACCOMMODATIVE
• 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: 8049231
• MDR Text Key: 126496875
• Report Number: 0001313525-2018-00200
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• 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-2250
• Device Lot Number: 7642923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2018
• Is the Reporter a Health Professional?: Yes
• Date Device Manufactured: 02/19/2016
• 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): Other
• Patient Age: 65 YR