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

Model Number VICMO12.6

Device Problems Device Operates Differently Than Expected (2913); Activation Failure (3270)

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

Event Date 08/08/2016

Event Type  malfunction  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).

Event Description

The reporter indicated the surgeon attempted to implant a 12.6mm vicmo12.6 implantable collamer lens, -11.0 diopter, in the patient's left eye (os) on (b)(6) 2016.The surgeon noticed the lens was folded and did not implant the lens.The backup lens was implanted.The patient's post-op best corrected visual acuity was 20/20.

Manufacturer Narrative

The lens was returned in a lens case/vial with clear surgical reside/debris on product.Visual inspection found the haptic bent and foreign material on lens surface (small particulates).(b)(4).

• 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 ; 6263037902
• MDR Report Key: 6109400
• MDR Text Key: 60231443
• Report Number: 2023826-2016-01645
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2018
• Device Model Number: VICMO12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2016
• Initial Date FDA Received: 11/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2015
• 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
• Patient Age: 23 YR