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

Model Number VICM512.1

Device Problem No Apparent Adverse Event (3189)

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

Event Date 02/13/2024

Event Type  malfunction  

Manufacturer Narrative

A4-a6:unk.(b)(4).

Event Description

The reporter indicated that a 12.1mm vicm512.1 implantable collamer lens of -3.50 diopter, was intraoperatively implanted, removed, and replaced for a longer length lens into the patient's right eye (od), on (b)(6) 2024 due to low vault without rotation.The problem was resolved.

• 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 ; 8002927902
• MDR Report Key: 19194326
• MDR Text Key: 341308230
• Report Number: 2023826-2024-01937
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00840311300143
• UDI-Public: 00840311300143
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VICM512.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2024
• Initial Date FDA Received: 04/26/2024
• Date Device Manufactured: 09/07/2023
• 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 - LOT# UNK; FOAM TIP PLUNGER LOT# UNK; INJECTOR MODEL: MSI-PF - LOT# UNK
• Patient Age: 21 YR
• Patient Sex: Female