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

Model Number VICMO12.6

Device Problems Failure to Unfold or Unwrap (1669); Activation Failure (3270)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The reporter indicated the surgeon implanted a 12.6mm vicmo12.6, -04.50 diopter implantable collamer lens in the patient's left eye (b)(6) 2016.The lens would not unfold in the eye.The lens was removed and exchanged with a similar lens.This resolved the problem.No adverse event was reported.

Manufacturer Narrative

The lens was returned in liquid, in a lens case/vial.Visual inspection found the lens haptic torn/broken/bent/deformed and the lens having foreign material on lens surface.No additional similar complaint event within associated lots was found.(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: 5613093
• MDR Text Key: 43847006
• Report Number: 2023826-2016-00542
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 04/04/2016

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: 07/31/2018
• Device Model Number: VICMO12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2016
• Initial Date FDA Received: 04/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2015
• 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: 35 YR