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

Model Number MICL13.2

Device Problems Inadequacy of Device Shape and/or Size (1583); Unintended Movement (3026)

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

Event Date 12/15/2014

Event Type  malfunction  

Event Description

The reporter stated the surgeon inserted a 13.2mm micl13.2 implantable collamer lens and the lens was noted to be upside down.The lens was also too long for the patient's eye.The lens was removed within the same surgery with no patient injury.The lens was exchanged for a shorter lens and the problem was resolved.

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.(b)(4).

Manufacturer Narrative

Results - visual inspection of the returned product found pieces of both haptics torn off and missing.The lens was returned dry and there was evidence of dried surgical residue on the lens surface.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: 4362750
• MDR Text Key: 16990984
• Report Number: 2023826-2014-01156
• 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: 12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2015
• Device Model Number: MICL13.2
• Other Device ID Number: DIOPTER -12.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2014
• Initial Date FDA Received: 12/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2013
• 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: CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK; INJECTOR MODEL MSI-PF - LOT NUMBER UNK; FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK
• Patient Age: 47 YR