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

Model Number	VICM5_12.6
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm vicm5 12.6, -9.50 diopter, implantable collamer lens into the patient's right eye (od) on 31/aug/2023.Low vault was observed.The lens remains implanted.Cause of the event is reported as patient related factor.Device did not fail to perform as intended.
Additional Manufacturer Narrative
A4 - unk.A5 - unk.A6 - unk.H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: b5: reportedly, "icl vaults are too low and i'm seeing some early cataract development, so will need to do an exchange".Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: h6: 4629-lens was explanted on an unknown date.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: originally the claim was determined to be reportable, but upon further review was determined to not meet definition of a complaint.However, the claim cannot be voided as an mdr has already been submitted.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: 17986862
• Report Number: 2023826-2023-04597
• Device Sequence Number: 18192575
• Product Code: MTA
• UDI-Device Identifier: 00841542119177
• UDI-Public: 00841542119177
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/02/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: VICM5_12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 11/21/2023; 01/05/2024; 02/13/2024
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 12/21/2023; 01/18/2024; 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2022
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL#SFC-45,LOT#UNK; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK; INJECTOR MODEL#LIOLI-24,LOT#UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female