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

Model Number AT50AO

Device Problem Malposition of Device (2616)

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

Event Date 06/09/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the lens in the patient's right eye was malpositioned.At one and a half months post-op, the doctor was unable to reposition it so the lens was explanted and the same model and diopter was implanted.

Manufacturer Narrative

The lens was returned to bausch and lomb.Visual inspection found the lens in three pieces.The optic has been torn in half.One plate is torn off and one haptic is bent.The cause of the damage cannot be determined.Functional and dimensional testing cannot be performed due to the damage.The device history record was reviewed and there were no discrepancies or unusual finding that relate to the reported issue.Based on the current information the root cause of the event could not be conclusively determined.

• Brand Name: CRYSTALENS ACCOMMODATING IOL
• Type of Device: LENS, INTRAOCULAR, ACCOMMODATIVE
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 10574 acacia street suite d1; rancho cucamonga CA 91730
• Manufacturer Contact: sharon spencer ; 50 technology drive west; irvine, CA 92618 ; 9493985698
• MDR Report Key: 5777540
• MDR Text Key: 49020454
• Report Number: 0001313525-2016-00303
• Device Sequence Number: 1
• Product Code: NAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: AT50AO
• Device Lot Number: 7368716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2013
• 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: 35 YR