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

Model Number VTICM5_13.2

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Blurred Vision (2137); Visual Impairment (2138); No Code Available (3191)

Event Date 10/06/2016

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 13.2 mm vticm5_13.2 implantable collamer lens, -12/03/78 diopter in the patient's left eye (os) on (b)(6) 2016.The lens was explanted on (b)(6) 2016 due to refractive surprise and loss of bcva (best corrected visual acuity).The lens was exchanged for another lens vticm 13.2 mm -12/03/79 diopter.The problem was resolved after the lens was exchanged.The patient's post-op best corrected visual acuity was 20/20.

Manufacturer Narrative

The lens tore/broke during injection/delivery into the eye.(b)(4).

Manufacturer Narrative

Device evaluation: product evaluation found that the lens was returned dry in the lens case/vial with clear surgical residue/debris on product.Visual inspection found the haptic broken.Dimensional inspection and functional inspection found lens was within specification.Work order search: no similar complaints were reported for units within the same lot.(b)(4).The lens was exchanged for a 13.2 mm vticm5_13.2, not a vticm.(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: 6211496
• MDR Text Key: 63473421
• Report Number: 2023826-2016-01841
• 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: 11/28/2016

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: 05/31/2019
• Device Model Number: VTICM5_13.2
• 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: 11/28/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/07/2017; 04/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2016
• 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: 25 YR