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

Model Number AT50AO

Device Problems Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616)

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

Event Date 10/21/2015

Event Type  Injury  

Manufacturer Narrative

Investigation is underway.A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that the lens vaulted two months post op.Anterior displacement with inferior lens vault was noticed on (b)(6) 2015.Pco and striae were identified.Lens repositioning is scheduled.The surgeon believes the likely cause of the event is pco, striae, capsular contraction and phimosis.The patient's current prognosis is iol repositioning and ctr.

Manufacturer Narrative

The lens remains implanted; therefore it is not available for evaluation.Inspection on a retain sample from the same lot was performed with all dimensional measurements found to be within specification.The lot history record was reviewed and there were no non-conformities or anomalies related to this complaint.Based on the information provided, the exact root cause of the event cannot be 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: 5231132
• MDR Text Key: 31453321
• Report Number: 0001313525-2015-02949
• 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: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: AT50AO
• Device Lot Number: 7554804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2015
• 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: 64 YR