MAUDE Adverse Event Report: STAAR SURGICAL COMPANY VISIAN ICL (IMPLANTABLE COLLAMER LENS); INTRAOCULAR LENS

Model Number MICL 12.6

Device Problem Bent (1059)

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

Event Date 05/08/2014

Event Type  malfunction  

Event Description

The reporter indicated the surgeon removed a 12.6mm micl 12.6 implantable collamer lens from the vial with the foam tip plunger and observed the footplate/haptic was bent 30 to 45 degrees.This was noted with the naked eye and was confirmed under the microscope.The lens was not implanted and there was no patient contact.The backup lens was implanted.

Manufacturer Narrative

(b)(6).(b)(4): evaluation codes: method - (other): work order search results - (other): a lens work order search was performed and no similar complaints were found within the work order.Visual inspection of the returned product found one footplate/haptic bent.The lens was returned dry.Conclusions - (no conclusion can be drawn): based on the complaint history, work order search and the evaluation of the returned product, a specific root cause of the event could not be determined.(b)(4).

Manufacturer Narrative

Evaluation: method - device history record review.Results - the lens was re-hydrated and cosmetic inspection did not detect any cosmetic defect on the lens.A review of the device history record was performed and nothing was found in the manufacturing, sterilization and packaging processes of this lens that was the root cause of the complaint.The most likely root cause is that the lens was stuck on the upper side of the vial and the haptic was not in the liquid for a certain time.During this time the haptic could have been dried and the haptic folded up.Conclusions - based on the complaint history, work order search, device history record review and the evaluation of the returned product, the most likely root cause of the event is that the lens was stuck on the upper side of the vial and the haptic was not in the liquid for a certain time.During this time the haptic could have been dried and the haptic folded up.(b)(4).

• Brand Name: VISIAN ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; haupstrasse 104; nidau, CH-25 60; SZ CH-2560
• Manufacturer (Section G): STAAR SURGICAL COMPANY; haupstrasse 104; nidau, CH-2 560; SZ CH-2560
• Manufacturer Contact: althea watson ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 3849505
• MDR Text Key: 4662412
• Report Number: 2023826-2014-00409
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2015
• Device Model Number: MICL 12.6
• Other Device ID Number: DIOPTER -12.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2013
• 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
• Treatment: INJECTOR MODEL AND LOT NUMBER UNK; FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK; CARTRIDGE MODEL AND LOT NUMBER UNK