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

Model Number VTICM5_12.6

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

Patient Problems Dizziness (2194); No Code Available (3191)

Event Date 07/12/2018

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.(b)(4).Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.6mm, vticm5_12.6, -9.00/1.5/082 (sphere/cylinder/axis), implantable collamer lens into the patients left eye (os) on (b)(6) 2018.The patient experienced dizziness and feeling seasick after initial surgery.It was reported that it was not refractive surprise.On (b)(6) 2018 the lens was exchanged for a non toric lens.This exchange resolved the problem.Cause of event was unknown.

Manufacturer Narrative

Device evaluation: lens was returned in liquid, in a micro-centrifuge vial.Visual inspection found no visible damage to 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: 8182688
• MDR Text Key: 130973720
• Report Number: 2023826-2018-01763
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 11/21/2018

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: 03/31/2021
• Device Model Number: VTICM5_12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 01/15/2019
• Supplement Dates FDA Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INJECTOR#MSI-PF,LOT#UNK,CARTRIDGE#SFC-45,LOT#UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR