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

Model Number VICM5_13.2

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/13/2020

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 13.2mm vicm5_13.2 implantable collamer lens, diopter -10.0 into the patient's left eye (os) on (b)(6) 2020.On (b)(6) 2020 the lens was exchanged with a longer lens due to low vault.The problem was resolved.

Manufacturer Narrative

Additional information: h3- device evaluation: lens was returned in a micro centrifuge vial with moisture and residue on the lens.Visual inspection found no visible damage with foreign residue on the lens.Claim# (b)(4).

Manufacturer Narrative

Additional information: this complaint is a follow up complaint.See mfr# 2023826-2020-02188 for the initial implant complaint (claim# (b)(4).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: 11098625
• MDR Text Key: 227803684
• Report Number: 2023826-2020-03242
• 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,Followup
• Report Date: 12/02/2020

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: 11/30/2022
• Device Model Number: VICM5_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: 12/15/2020
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 02/28/2021; 04/12/2021
• Supplement Dates FDA Received: 03/29/2021; 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR