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

Model Number VICM5 12.1

Device Problems Optical Distortion (3000); Optical Problem (3001)

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

Event Date 11/30/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The reporter indicated that a 12.1mm vicm5_12.1 implantable collamer lens of -4.00 diopter was implanted into the patient's right eye (od) on (b)(6) 2023.On 30-nov-2023 the lens was exchanged for a longer lens of the same model and power due to glare/haloes and the problem resolved.Cause of event was unknown.

Manufacturer Narrative

Corrected data: h6: medical device problem code: "3000" should be removed and "3001" should be added.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
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18508980
• MDR Text Key: 332868476
• Report Number: 2023826-2024-00216
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00840311300150
• UDI-Public: 00840311300150
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

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: VICM5 12.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 02/20/2024
• Supplement Dates FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2023
• 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 W/FTP, LOT# UNK.; INJECTOR MODEL: MSI-PF, LOT# UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female