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

Model Number VTICMO12.6

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 09/02/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The reporter indicated that the surgeon implanted a 12.6 mm vticmo12.6 implantable collamer lens, -10.5/+1.5/108 diopter in the patient's right eye (od) on (b)(6) 2016.The lens was explanted on (b)(6) 2016 due to low vaulting.The lens was exchanged for a longer lens and the problem was resolved.There was no report of any patient injury.

Manufacturer Narrative

(b)(6) date of event: (b)(6) 2016.Lens was exchanged on (b)(6) 2016.As of the date of supplemental mdr submission, lens has not yet been evaluated.Device mfr date: 11/04/2015; (corrected)-11/09/2015.(b)(4).

Manufacturer Narrative

Device evaluation: lens was returned dry in lens case/vial.Clear surgical residue/debris was present on the product.Visual inspection found that the haptic was bent.Conclusion: as per dfu for this lens model, implantation of this lens in an individual over the age of 45 years and with anterior chamber depth (acd) below 3.0mm is contraindicated.This patient was 47 years old at the time of implantation and had an acd of 2.88mm.Claim #(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: 6214738
• MDR Text Key: 63606545
• Report Number: 2023826-2016-01842
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: VTICMO12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/15/2017; 04/12/2017
• 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: 47 YR