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

Model Number AO1UV

Device Problems Break (1069); Torn Material (3024)

Patient Problem Capsular Bag Tear (2639)

Event Date 10/11/2017

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

Reportedly the capsule tore during iol insertion in the right eye due to lens torn haptic.The surgeon removed the lens and replaced with a lens of a different model and placing it in the sulcus.Currently the patient is doing well.

Manufacturer Narrative

The lens was not returned for evaluation.Device history records (dhr) were reviewed and no discrepancies or anomalies were found.Based on the available information it is concluded that user related or procedure related factors might have caused the event.The root cause of this event can 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; 21 north park place blvd.; clearwater 33759
• Manufacturer Contact: faranak gomarooni ; 50 technology drive west; irvine, CA 92618 ; 9493985708
• MDR Report Key: 7054340
• MDR Text Key: 92811336
• Report Number: 0001313525-2017-02846
• 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: Initial,Followup
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2020
• Device Model Number: AO1UV
• Device Lot Number: 7569527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2015
• 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
• Treatment: CRYSTALSERT INSERTER
• Patient Outcome(s): Other
• Patient Age: 58 YR