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

Model Number VICMO12.6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Touch (1794); No Code Available (3191)

Event Date 03/30/2016

Event Type  malfunction  

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 12.6mm vicmo12.6 implantable collamer lens, -11.50 diopter, in the patient's left eye (os).The reporter indicated haptics contacted the peripheral corneal endothelium.The lens remained implanted.The cause of the event was due to user error.The reporter indicated they didn't have experience in the early time when icl floated in the anterior chamber with the "ovd free" technique.This patient was part of a study comparing the safety of implantable collamer lens (icl) with and without ophthalmic viscosurgical device (ovd).

Manufacturer Narrative

Additional data: b5: the lens was implanted on (b)(6) 2016.Claim # (b)(4).

Manufacturer Narrative

Corrected data: h1: in initial mdr and supplemantal report should be corrected from serious to malfunction.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
• MDR Report Key: 10310632
• MDR Text Key: 199987334
• Report Number: 2023826-2020-01552
• 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,Followup
• Report Date: 06/26/2020

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: 08/31/2018
• Device Model Number: VICMO12.6
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/26/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 07/23/2020; 06/03/2021
• Supplement Dates FDA Received: 10/06/2020; 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR