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

Model Number VTICMO12.6

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

Patient Problems Visual Disturbances (2140); Halo (2227)

Event Date 11/11/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The reporter indicated that the surgeon implanted a 12.6mm vticmo12.6; -15.50/3.0/116 (sphere/cylinder/axis) implantable collamer lens into the patient's right eye (od) on (b)(6) 2022.The surgeon reports the patient had glare/halo that wasn't tolerable.On (b)(6) 2024 the lens was explanted.

Manufacturer Narrative

It was later additionally reported that the cause of the event was the device, and a patient related factor but the device did not fail to perform as intended was noted and "patient bothered by halo and glare at night.Non adapt to central aquaport".The problem was resolved.Patient is wearing soft contact lens after icl explant.Halo/glare not present when wearing soft contact lens.Claim#: (b)(4).

Manufacturer Narrative

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: 19029557
• MDR Text Key: 339215089
• Report Number: 2023826-2024-01559
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542120470
• UDI-Public: 00841542120470
• 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: 02/07/2024

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: VTICMO12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/03/2024; 05/09/2024
• Supplement Dates FDA Received: 04/04/2024; 05/09/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/23/2022
• 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: 29 YR
• Patient Sex: Female