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

Model Number	VICMO13.2
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Visual Disturbances (2140)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A4-a6:unk.H6: work order search: no similar complaints within associated lots were found.Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vicmo13.2 implantable collamer lens of a -15.0 diopter into the patient's eye.Patient subjective disturbance of "glare and halos" was reported.There is no visual acuity loss or loss of bcva reported and the lens remains implanted.The icl direcitons for use identifies glare and halo visual disturbance as a known potential adverse event.Patient risk factors include pre-existing/current ocular status and mesopic pupil size that is greater than the icl optic diameter.Based on the information received, the root cause of the reported event cannot be determined.
Additional Manufacturer Narrative
Correction/removal number: 2023826-10/16/2023-001-r.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 800 royal oaks dr. suite:210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18311165
• Report Number: 2023826-2023-05091
• Device Sequence Number: 20512905
• Product Code: MTA
• UDI-Device Identifier: 00841542122061
• UDI-Public: 00841542122061
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2023

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: 09/30/2024
• Device Model Number: VICMO13.2
• 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: 11/28/2023
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2022
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2023826-10/16/2023-001-R
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Patient Sex: Unknown