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

Model Number	VICM5 13.7
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Claim#(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.7mm vicm5_13.7 implantable collamer lens, -6.5 diopter into the patients left eye (os) on (b)(6) 2024.On (b)(6) 2024 the lens was exchanged with a shorter length lens due to excessive vault and significant reduction of iridocorneal angles.The problem was resolved.The cause of the event was unknown.
Additional Manufacturer Narrative
H6 investigation type 4110: lens work order search-no similar complaints reported for units within the same lot.(b)(4).
Additional Manufacturer Narrative
Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker ave; monrovia, CA 91016
• MDR Report Key: 19523840
• Report Number: 2023826-2024-02645
• Device Sequence Number: 18205651
• Product Code: MTA
• UDI-Device Identifier: 00840311301195
• UDI-Public: 00840311301195
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: VICM5 13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 09/01/2024; 09/23/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 09/01/2024; 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL-SFC-45, LOT#-UNK.; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK.; INJECTOR MODEL-MSI-PF, LOT#-UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female