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

Model Number VICMO13.2

Device Problems Inadequacy of Device Shape and/or Size (1583); Activation, Positioning or Separation Problem (2906)

Patient Problem No Code Available (3191)

Event Date 11/20/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The reporter indicated that the surgeon implanted a 13.2 mm vicmo13.2 implantable collamer lens, -8.50 diopter in the patient's left eye (os) on (b)(6) 2016 and the lens was noted to be torn during injection/delivery into the eye.The lens was explanted on (b)(6) 2016 due to excessive vaulting and lens tear.The lens was exchanged for a shorter lens and the problem was resolved.The patient's post-op best corrected visual acuity was 20/20.

Manufacturer Narrative

Additional data: work order search: no similar complaints were reported for units within the same lot.(b)(4).

Manufacturer Narrative

The lens was returned dry in a micro centrifuge vial and had clear surgical residue/ debris on the product.Visual inspection found the lens haptic bent and a piece of haptic missing.There was clear residue on the 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 ; 6263037902
• MDR Report Key: 6199638
• MDR Text Key: 63133327
• Report Number: 2023826-2016-01813
• 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,Followup,Followup
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2018
• Device Model Number: VICMO13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR