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

Model Number	VICMO 13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm, vicmo 13.2, -16.0 diopter, implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2024.Excessive vault was observed.Lens remains implanted.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
Additional information: b5 - the reporter indicated that a 13.2mm, vicmo13.2, -16.0 diopter, implantable collamer lens was implanted into the patient's right eye (os) on (b)(6) 2024.Excessive vault and lens opacity (cataract) was observed.Lens explanted on (b)(6) 2024.Problem resolved.H1 - reported as malfunctions - update to serious injury.H6 - health effect - impact code(f) - reported as 2199 - update to 4627.D6b - 16-may2024.Claim# (b)(4).
Additional Manufacturer Narrative
Additiona/correction information: b1 - reported as product problem - adverse event.B2 - reported as -blank- report as required intervention to prevent permanent impairment/damage.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: 19226728
• Report Number: 2023826-2024-01893
• Device Sequence Number: 6732745
• Product Code: MTA
• UDI-Device Identifier: 00840311302536
• UDI-Public: 00840311302536
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2024

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: 03/31/2026
• Device Model Number: VICMO 13.2
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 07/02/2024; 07/08/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 07/03/2024; 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2023
• 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#1662672.; FOAMTIPPLUNGER MODEL#FTP,LOT#1660152.
• Patient Sex: Female