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

Model Number AT52AO

Device Problem Positioning Problem (3009)

Patient Problem Vitrectomy (2643)

Event Date 04/09/2014

Event Type  No Answer Provided  

Event Description

It was reported that zonular laxity was noted intraoperatively by the surgeon and a capsular tension ring was placed.Also, it was reported that during lens insertion the lens "flipped" resulting in tearing of subincisional zonules and loss of vitreous.The incision was enlarged to remove the lens, vitrectomy was performed and anterior chamber lens was implanted.This event is for the patient' right eye.The current prognosis was reported as "pt is doing well with anterior chamber lens." ref 2031924-2014-00092 for 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: LENS, INTRAOCULAR, ACCOMODATIVE
• Manufacturer (Section D): BAUSCH + LOMB; aliso viejo CA
• Manufacturer Contact: sharon spencer, director, qualit ; 50 technology dr; irvine, CA 92618 ; 9493985698
• MDR Report Key: 3814953
• MDR Text Key: 4400076
• Report Number: 2031924-2014-00091
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: AT52AO
• Device Lot Number: 7442201
• Other Device ID Number: 12.00 D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2014
• 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: CRYSALSERT CRYSTALENS DELIVERY SYSTEM
• Patient Outcome(s): Other
• Patient Age: 84 YR