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

Model Number VICM512.6

Device Problems Patient-Device Incompatibility (2682); Optical Problem (3001)

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

Event Date 01/15/2024

Event Type  Injury  

Event Description

The reporter indicated that 12.6mm vicm512.6 implantable collamer lens of a -10.0 diopter was implanted into the patient's left eye (os) on (b)(6) 2023.On (b)(6) 2024, the lens was removed due to glare and halos.

Manufacturer Narrative

A4-a6:unk.H6: work order search: no similar complaints within associated lots were found.Claim# (b)(4).

Manufacturer Narrative

Claim#:(b)(4).

Manufacturer Narrative

Cause of the event was a patient-related-factor with the device not failing to perform as intended.The problem was resolved.It is reported that glares and halos are gone.Device not evaluated by manufacturer.Added 2140 - visual disturbance added 2682 - patient-related-factor work order search was completed but was not required.(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
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 800 royal oaks dr. suite: 210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18591876
• MDR Text Key: 333872537
• Report Number: 2023826-2024-00347
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542119184
• UDI-Public: 00841542119184
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2024

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 Expiration Date: 04/30/2024
• Device Model Number: VICM512.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 01/26/2024
• Supplement Dates Manufacturer Received: 02/01/2024; 03/24/2024
• Supplement Dates FDA Received: 02/09/2024; 03/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/16/2022
• 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: CARTRIDGE MODEL: SFC-45 - LOT# UNK; FOAM TIP PLUNGER - LOT #UNK; INJECTOR MODEL: MSI-PF - LOT# UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female