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

Model Number	VICM5 12.6
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2 - unk.A3 - unk.A4 - unk.A5 - unk.A6 - unk.B3 - unk.D2 - product code: unk (esubmitter software does not allow for a blank or 'unk' entry).D4 - unk.D6a - unk.H4 - unk.Claim# (b)(4).
Event or Problem Description
The reporter indicated that an implantable collamer lens was implanted into the patient's right (od) eye.Refractive surprise was observed.Lens remains implanted.Additional information has been requested but none has been forthcoming.
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm vicm512.6, -6.0 diopter, implantable collamer lens into the patient's right eye (od) on (b)(6) 2023.Refractive change overtime was observed.Lens remains implanted.Cause of the event is reported as unknown.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
Additional information: provided throughout form.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: b5 - reported as; the reporter indicated that the surgeon implanted a 12.6mm vicm512.6, -6.0 diopter, implantable collamer lens into the patient's right eye (od) on 29/nov/2023.Refractive change overtime was observed.Lens remains implanted.Cause of the event is reported as unknown.Correct to; a healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced refractive change overtime.In a separate visit the lens was exchanged for a replacement lens of same length different power.The problem was resolved.Cause of the event was reported as unknown.D4 udi reported as; (b)(4) ; update to; (b)(4).H6 health effect - impact code (f): reported as; 2199 - update to; 4629.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 avenue; monrovia, CA 91016
• MDR Report Key: 19654570
• Report Number: 2023826-2024-02870
• Device Sequence Number: 20545207
• Product Code: MTA
• UDI-Device Identifier: 00840311300525
• UDI-Public: 00840311300525
• 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: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: VICM5 12.6
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: 07/02/2024; 02/24/2025
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/09/2024; 03/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/30/2023
• 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.; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK.; INJECTOR MODEL#MSI-PF,LOT#UNK.; UNK.
• Patient Sex: Female