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

Model Number VICM512.6

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

Patient Problem Blurred Vision (2137)

Event Date 03/12/2024

Event Type  Injury  

Event Description

The reporter indicated that a 12.6mm vicm512.6 implantable collamer lens of -10.50 diopter was implanted into the patient's left eye (os) on (b)(6) 2024.On (b)(6) 2024, the lens was exchanged for a same size, different power lens due to refractive surprise.Cause of the event is unknown.Status of the eye is "correct." the problem was resolved.

Manufacturer Narrative

H6: work order search: no similar complaints within associated lots were found.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 ; 800 royal oaks dr. suite:210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 19185405
• MDR Text Key: 341081045
• Report Number: 2023826-2024-01781
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00840311300617
• UDI-Public: 00840311300617
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 04/10/2024

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: VICM512.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/25/2024
• Date Device Manufactured: 10/11/2023
• 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-TF - LOT# UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male