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

Model Number VICMO13.2

Device Problems Misfocusing (1401); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blurred Vision (2137)

Event Date 05/26/2023

Event Type  Injury  

Manufacturer Narrative

A4: a6:unk.H6: work order search: no similar complaints within associated lots were found.Claim#: 734061.

Event Description

The reporter indicated that a 13.2mm vicmo13.2 implantable collamer lens of -6.0 diopter was implanted into the patient's right eye (od) on (b)(6) 2023.On (b)(6) 2024, the lens was exchanged for same size, different power lens due to refractive surprise and refractive change overtime.The problem was resolved.Cause of the event is unknown.

Manufacturer Narrative

A2 - d.O.B.: (b)(6) 2023 corrected to (b)(6) 2001 in initial mdr h6 - 2993 claim #(b)(4).

Manufacturer Narrative

H3 - device evaluation: the lens was returned dry with residue/debris in a microcentrifuge vial.Visual inspection found no visible damage to the lens.Dimensional inspection found the lens to be within specifications.(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: 18803156
• MDR Text Key: 336487706
• Report Number: 2023826-2024-00837
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/19/2023

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: VICMO13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/07/2024
• Date Device Manufactured: 10/03/2022
• 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: 22 YR
• Patient Sex: Male