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

Model Number VICMO12.6

Device Problems Misfocusing (1401); Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyphema (1911); Blurred Vision (2137); Visual Disturbances (2140)

Event Date 12/14/2023

Event Type  Injury  

Event Description

The reporter indicated that a 12.6mm vicmo12.6 implantable collamer lens of -5.5 diopter was implanted into the patient's right eye (od) on (b)(6) 2023.On (b)(6) 2024, the lens was removed due to hyphema and the problem was resolved.Cause of the event is unknown.

Manufacturer Narrative

A4-a6:unk.H6: off-label acd<3.0.Claim# (b)(4).

Manufacturer Narrative

(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 ; 8002927902
• MDR Report Key: 18591877
• MDR Text Key: 333894537
• Report Number: 2023826-2024-00345
• 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: 01/16/2024

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: VICMO12.6
• Was Device Available for Evaluation?: No
• 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: 04/28/2024
• Supplement Dates FDA Received: 04/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 32 YR
• Patient Sex: Female