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

Model Number	VICM5 12.6
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Optical Problem (3001)
Health Effect - Clinical Codes	Headache (1880); Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 12.6mm, vicm5_12.6, -12.0 diopter, implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2023.The lens was explanted on (b)(6) 2023 due to glare/haloes.This resolved the problem.Cause of the event is reported as patient related factor; patient complains of headache.
Additional Manufacturer Narrative
H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
Additional Manufacturer Narrative
B5 - it is unknown if this resolved the problem.Claim # (b)(4).
Additional Manufacturer Narrative
B5 - the problem is resolved.Additional information provided "patient is happy".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: 18552583
• Report Number: 2023826-2024-00251
• Device Sequence Number: 7597547
• Product Code: MTA
• UDI-Device Identifier: 00840311300648
• UDI-Public: 00840311300648
• 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: 2023
• 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): 01/04/2024

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 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: 01/04/2024
• Supplement Date Received by Manufacturer: 04/03/2024; 07/24/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 04/03/2024; 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male