MAUDE Adverse Event Report: STAAR SURGICAL COMPANY EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS; PHAKIC INTRAOCULAR LENS

Model Number	VICM5 13.7 (-7.50)
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	12/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - clinical code 4581: lens dislocation/subluxation.(b)(4).
Event or Problem Description
A healthcare professional reported that during an implantable collamer lens (icl) implantation procedure the lens was implanted upside down.The patient experienced lens dislocation/subluxation.The lens was implanted, removed, and exchanged intraoperatively for a lens of the same size and power.Cause of the event was reported as unknown.The problem was resolved.
Additional Manufacturer Narrative
Corrected data: h6.- health effect - impact code (f): "4629" should be removed and "2199" should be added.H6- investigation type code: "4110- lens work order search-no similar complaint event(s) within associated lots were found." should be added.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: b3.-date of event: "04/12/2025" should be removed and "12/04/2024" should be added.D6a.-if implanted, give date: "(b)(6) 2024" should be removed and " (b)(6) 2024" should be added.D6b.-if explanted, give date: " (b)(6) 2024" should be removed and " (b)(6) 2024" should be added.Claim# (b)(4).

• Brand Name: EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker ave; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 21997452
• Report Number: 2023826-2025-00665
• Device Sequence Number: 9412336
• Product Code: MTA
• UDI-Device Identifier: 00840311301218
• UDI-Public: (01)00840311301218(11)231207(17)261130
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2025

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 Model Number: VICM5 13.7 (-7.50)
• Device Catalogue Number: VICM5 13.7
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 06/02/2025; 07/01/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/02/2025; 07/01/2025
• Date Device Manufactured: 12/07/2023
• 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, LOT UNK; INJECTOR MODEL: MSI-PF, LOT # UNK
• Outcome Attributed to Adverse Event: Other
• Patient Age: 23 YR
• Patient Sex: Male