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

Model Number AT50AO

Device Problem Mechanical Jam (2983)

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

Event Date 06/05/2014

Event Type  Injury  

Event Description

It was reported that during implantation the lens haptic got stuck in the delivery device.The incision was enlarged to remove the lens intraoperatively and another lens was implanted.Sutures were used to close the wound.The patient's prognosis was reported as "excellent".Please reference mdr# 2031924-2014-00150 for the inserter used during the event.

Manufacturer Narrative

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

• Brand Name: CRYSTALENS ACCOMMODATING IOL
• Type of Device: NAA/LENS, INTRAOCULAR, ACCOMMODATIVE
• Manufacturer (Section D): BAUSCH + LOMB; rancho cucamonga CA
• Manufacturer Contact: sharon spencer, dir qa ; 50 technology drive; irvine, CA 92618 ; 9493985698
• MDR Report Key: 3946299
• MDR Text Key: 20655418
• Report Number: 2031924-2014-00149
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: AT50AO
• Device Lot Number: 7371505
• Other Device ID Number: 17.50 D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2014
• 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: CI-28 CRYSTALSERT DELIVERY DEVICE
• Patient Outcome(s): Other
• Patient Age: 61 YR