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

Model Number VICMO12.6

Device Problem Activation Failure (3270)

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

Event Date 02/24/2017

Event Type  malfunction  

Manufacturer Narrative

This product is not marketed in the us.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.6mm vicmo12.6 implantable collamer lens, -18.00 diopter, in the patient's left eye (os) on (b)(6) 2017.It was documented that at the first instance, the lens unfolded, and was implanted upside down.During explant, the lens tore.On the same surgery, the lens was exchanged, and the problem was resolved.As of the date of mdr submission, the lens has not been returned.

Manufacturer Narrative

Product evaluation found that the lens was returned in a small vial.Visual inspection found the haptic missing a piece and debris and residue on lens surface.(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
• MDR Report Key: 6438974
• MDR Text Key: 71016145
• Report Number: 2023826-2017-00497
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 02/28/2017

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: 10/31/2019
• Device Model Number: VICMO12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2017
• Initial Date FDA Received: 03/28/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2016
• 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
• Patient Age: 24 YR