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

Model Number	VTICM5 13.2
Medical Device Problem Codes	Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4,a5, a6-unk.H6-investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm vticm5 13.2 implantable collamer lens of -10.00/1.0/015 (sphere/cylinder/axis) was implanted into the patients right eye (od) on (b)(6) 2023.Excessive vault is reported.Reportedly, the lens remains implanted.The cause of event is reported as other: icl calculation software and/or wtw from device (alcon biograph) over sizing.Per reporter the ocos software worked as intended, but the outcome was not expected.
Additional Manufacturer Narrative
H6 - medical device problem code 1494: off-label use (safety and effectiveness of the lens has not been established in patients with: keratoconus).Claim # (b)(4).
Additional Manufacturer Narrative
B5 - the reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens of diopter -10.0/1.0/015 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2023.The lens was exchanged for a same model and shorter length lens on (b)(6) 2023 due to excessive vault.Per follow up email "the vault remained at around 800 microns on 1 and 3 months postoperative emaxminations".Claim #(b)(4).
Additional Manufacturer Narrative
H3 - device evaluation: the lens was returned found the lens returned in liquid with residue/debris on the lens in a microcentrifuge vial.Visual inspection found the haptic torn.Dimensional inspection found the lens to be within specifications.Claim #(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: IMPLANTABLE TORIC COLLAMER 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 ; 6263037902
• MDR Report Key: 17980732
• Report Number: 2023826-2023-04712
• Device Sequence Number: 2467098
• Product Code: QCB
• UDI-Device Identifier: 00840311311187
• UDI-Public: 00840311311187
• Combination Product (Y/N): N
• 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,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/29/2024

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?: Yes
• Device Expiration Date: 04/30/2026
• Device Model Number: VTICM5 13.2
• 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: 09/22/2023
• Supplement Date Received by Manufacturer: 12/19/2023; 12/27/2023; 01/29/2024
• Initial Report FDA Received Date: 10/20/2023
• Supplement Report FDA Received Date: 12/19/2023; 01/08/2024; 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2023
• 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.; FOAM TIP PLUNGER (FTP), LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Female