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

Model Number VTICM5_12.6

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

Patient Problems Cataract (1766); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/16/2023

Event Type  Injury  

Event Description

The reporter indicated that the surgeon implanted a 12.6mm tmicl12.6; -8.50/2.0/089 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6)2023.The surgeon reports there was a cataract, glare/haloes, dysphotopsia, blurred vision, and on (b)(6) 2023 the lens was explanted and phaco-emulsification and iol implantation was performed.This resolved the problem.The cause of the event was reported as unknown.

Manufacturer Narrative

H6 - health effect clinical code: 4581 - dysphotopsia.H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).

Manufacturer Narrative

Corrected data: b5 - "on 10-nov-2023 the lens was explanted." should be corrected to "on 10-apr-2024 the lens was explanted" claim#: (b)(4).

Manufacturer Narrative

Corrected data: b5 - tmicl12.6 should be corrected to vticm5_12.6.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 19137902
• MDR Text Key: 340565931
• Report Number: 2023826-2024-01852
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542114776
• UDI-Public: 00841542114776
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2024

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 Model Number: VTICM5_12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 07/09/2024; 08/06/2024
• Supplement Dates FDA Received: 07/09/2024; 08/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INJECTOR MODEL-LIOLI-24, LOT#-UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male