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

Model Number VICMO12.1

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

Patient Problem No Code Available (3191)

Event Date 10/25/2018

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 the surgeon implanted a 12.1mm vicmo12.1 implantable collamer lens, -06.50 diopter, in the patient's right eye (od) on (b)(6) 2018.The lens was explanted on (b)(6) 2018 due to low vaulting.The lens was exchanged for a longer lens and the problem was resolved.The reporter indicated the cause of the event was unknown.

Manufacturer Narrative

Device evaluation: lens was returned dry in a micro-centrifuge vial.There was clear surgical residue on product.Visual inspection found the haptic bent and presence of residue on lens surface.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 8204853
• MDR Text Key: 131696547
• Report Number: 2023826-2018-01933
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

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: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: VICMO12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 02/08/2019
• Supplement Dates FDA Received: 03/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR