MAUDE Adverse Event Report: STAAR SURGICAL COMPANY INTRAOCULAR LENS; IMPLANTABLE COLLAMER LENS

Model Number VTICMO12.1

Device Problems Crack (1135); Device Operates Differently Than Expected (2913)

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

Event Date 10/07/2016

Event Type  malfunction  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).Device evaluation - product evaluation found that the lens was returned in liquid, with clear surgical residue/debris on the product, and in the lens case/vial.Visual inspection found the haptic broken with dried, discolored material on the lens surface.(b)(4).

Event Description

The reporter indicated that a 12.1mm vticmo12.1 implantable collamer lens, had cracked just when the lens was coming out from the injector.This occurred on (b)(6) 2016, before injecting into the left eye (os).The lens was not implanted and there is no reported patient injury.This lens has been returned and evaluated.

Manufacturer Narrative

(b)(4).No reported material integrity issue.(b)(4).

• Brand Name: INTRAOCULAR LENS
• Type of Device: IMPLANTABLE COLLAMER LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 6280828
• MDR Text Key: 65857576
• Report Number: 2023826-2017-00163
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2019
• Device Model Number: VTICMO12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2016
• 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 AND LOT NUMBER UNK; INJECTOR MODEL AND LOT NUMBER UNK
• Patient Age: 42 YR