MAUDE Adverse Event Report: BAUSCH & LOMB, INC. CRYSTALENS HD IOL; LENS, INTRAOCULAR, ACCOMODATIVE

Model Number HD500

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Visual Impairment (2138)

Event Date 04/03/2015

Event Type  Injury  

Event Description

It was reported that approximately 6 years post lens implant, the lens optic was described as having white marks/lens deposits and the patient had blurred vision.A yag procedure was performed.This event refer's to the patient's left eye.

Manufacturer Narrative

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

Manufacturer Narrative

The lens was not returned to the manufacturer for evaluation.The device history records were reviewed and there were no discrepancies or unusual finding that relate to the reported issue.Based on the information available, the root cause of the reported event could not be determined.

• Brand Name: CRYSTALENS HD IOL
• Type of Device: LENS, INTRAOCULAR, ACCOMODATIVE
• Manufacturer (Section D): BAUSCH & LOMB, INC.; rochester NY
• Manufacturer Contact: sharon spencer ; 50 technology drive; irvine, CA 92618 ; 9493985698
• MDR Report Key: 4873897
• MDR Text Key: 6048088
• Report Number: 1313525-2015-01837
• 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,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2013
• Device Model Number: HD500
• Device Lot Number: 015365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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: 66 YR