MAUDE Adverse Event Report: BAUSCH & LOMB CRYSTALENS INTRAOCULAR LENS; LENS, INTRAOCULAR, ACCOMMODTIVE

Model Number AT50AO

Device Problem Torn Material (3024)

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

Event Date 11/20/2014

Event Type  Injury  

Event Description

It was reported that the lens was not loaded properly and the trailing haptic tore off when injecting the lens.The incision was enlarged to remove the lens.Another lens of the same model was implanted successfully.Pt's prognosis is good.The inserter that was used during this event is reported under 2031924-2014-00326.

Manufacturer Narrative

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

• Brand Name: CRYSTALENS INTRAOCULAR LENS
• Type of Device: LENS, INTRAOCULAR, ACCOMMODTIVE
• Manufacturer (Section D): BAUSCH & LOMB; rancho cucamonga CA
• Manufacturer Contact: sharon spencer ; 50 technology drive; irvine, CA 92618 ; 9493985698
• MDR Report Key: 4337663
• MDR Text Key: 5219038
• Report Number: 2031924-2014-00325
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: AT50AO
• Device Lot Number: 7453709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 INJECTOR
• Patient Outcome(s): Other
• Patient Age: 63 YR