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

Model Number MICL 13.7

Device Problem Difficult to Insert (1316)

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

Event Date 02/27/2014

Event Type  malfunction  

Event Description

The reporter stated the surgeon loaded a 13.7mm micl 13.7 implantable collamer lens but had difficulty inserting the lens.Upon injection of the lens from the cartridge, the lens was twisting.The surgeon loaded and attempted to insert the same lens two more times but was unable to do so.There was patient contact but no injury.The backup lens was implanted with no problem.

Manufacturer Narrative

(b)(4) - no known impact or consequence to patient.Difficult to insert.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 no visible damage to the lens.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: 3723120
• MDR Text Key: 4272584
• Report Number: 2023826-2014-00249
• 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
• Report Date: 03/06/2014

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: 07/31/2014
• Device Model Number: MICL 13.7
• Other Device ID Number: DIOPTER -9.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2014
• Initial Date FDA Received: 04/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2012
• 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: FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK; INJECTOR MODEL MSI-PF - LOT NUMBER UNK; CARTRIDGE MODEL SFC-45 FP - LOT NUMBER UNK
• Patient Age: 26 YR