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

Model Number MICL 12.6

Device Problem Difficult to Insert (1316)

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

Event Date 08/19/2014

Event Type  malfunction  

Event Description

The reporter stated the surgeon inserted a 12.6mm micl 12.6 implantable collamer lens but was unable to get the lens through the incision.The lens was partially in the eye, and was removed with no patient injury.The backup lens was implanted with no problem.The reporter stated there was no issue/problem with the lens or injection system, the surgeon decided to use the backup lens as he did not want to damage the patient's eye by forcing the lens in.There was no incision enlargement or sutures used.

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.Conclusions - based on the complaint history and work order search, a specific root cause of the event could not be determined.(b)(4).

Manufacturer Narrative

Results: visual inspection of the returned product found no visible damage to the lens.The lens was returned in liquid.The injector, cartridge and foam tip plunger were not returned.Conclusions: based on the complaint history, work order search and the evaluation of the returned product, a likely cause of the event has been determined to be due to surgeon's decision not to use the lens.The event was not product related.(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: 4094103
• MDR Text Key: 15807090
• Report Number: 2023826-2014-00717
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/20/2014

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: MICL 12.6
• Other Device ID Number: DIOPTER -9.0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/16/2014
• Initial Date FDA Received: 09/16/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2013
• 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 AND LOT NUMBER UNK; FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK
• Patient Age: 25 YR