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

Model Number VICMO12.6

Device Problem Incomplete or Missing Packaging (2312)

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

Event Date 02/17/2017

Event Type  malfunction  

Manufacturer Narrative

This product is not marketed in the us.Work order search performed, one similar complaint was reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.6mm vicmo12.6 implantable collamer lens in the patient's eye on (b)(6) 2017.The surgeon found that the serial number label on the lens case ((b)(4)) didn't match the serial number label on the outside of the box ((b)(4)).Lens remains implanted, will not be returned.Reference mdr 2023826-2017-00410.

• Brand Name: ICL (IMPLANTABLE COLLAMER LENS)
• Type of Device: PHAKIC INTRAOCULAR 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
• MDR Report Key: 6425335
• MDR Text Key: 70639621
• Report Number: 2023826-2017-00450
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• 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
• Report Date: 02/22/2017

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: 09/30/2018
• Device Model Number: VICMO12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2015
• 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