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

Model Number AT50AO

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/24/2015

Event Type  Injury  

Manufacturer Narrative

The lens has been returned to b+l and is currently under evaluation.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 doctor noticed z-syndrome approximately 13 weeks post lens implant.The doctor tried to reposition the lens approximately 15 weeks post implant without success.The lens was explanted and exchanged with another model lens, but the lens haptics remain in the eye.The surgeon indicated the likely cause of the event was capsular fibrosis.The patient's current status is good.

Manufacturer Narrative

The lens was returned to b+l.Visual inspection found portion of both haptic plates missing.Due to the condition in which the lens was returned further testing could not be performed.One retain sample from the same lot (025179) was inspected and all measurements were found to be within specifications.The device history records were reviewed and there were no discrepancies or unusual finding that relate to the reported issue.Based on the current information, the specific root cause of the event could not be determined.

• Brand Name: CRYSTALENS ACCOMMODATING IOL
• Type of Device: LENS, INTRAOCULAR, ACCOMMODATIVE
• Manufacturer (Section D): BAUSCH & LOMB INCORPORATED; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 10574 acacia street suite d1; rancho cucamonga CA 91730
• Manufacturer Contact: sharon spencer ; 50 technology drive; irvine, CA 14609 ; 9493985698
• MDR Report Key: 5099225
• MDR Text Key: 26597205
• Report Number: 0001313525-2015-02628
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2018
• Device Model Number: AT50AO
• Device Lot Number: 025179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2013
• 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: 70 YR