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

Model Number	VICMO 12.6
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that a 12.6mm vicm5 12.6 implantable collamer lens of -4.00 diopter was implanted into the patients left eye (os) on (b)(6) 2023.Ghosting images are reported and patient is being monitored.The lens remains implanted.No further information has been provided.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
H6-investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.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: 18079674
• Report Number: 2023826-2023-04800
• Device Sequence Number: 18074787
• Product Code: MTA
• UDI-Device Identifier: 00840311300488
• UDI-Public: 00840311300488
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2023

1 Device was Involved in the Event

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: 05/31/2026
• Device Model Number: VICMO 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: 10/09/2023
• Initial Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2023
• 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
• Patient Sex: Unknown