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

Model Number MICL 12.6

Device Problems Bent (1059); Torn Material (3024)

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

Event Date 11/19/2014

Event Type  malfunction  

Event Description

The reporter stated the surgeon was inserting a 12.6mm micl 12.6 implantable collamer lens and noted one haptic was bent/damaged.There was no patient contact and the backup lens was implanted.

Manufacturer Narrative

(b)(4): evaluation: method - work order search.Results - 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 haptic torn, with a piece torn off and missing.The lens was returned in liquid.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).

• 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: 4327318
• MDR Text Key: 16178386
• Report Number: 2023826-2014-01108
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2015
• Device Model Number: MICL 12.6
• Other Device ID Number: DIOPTER -15.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2013
• 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; CARTRIDGE MODEL AND LOT NUMBER UNK