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

Model Number	VTICM5_12.1
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
Event or Problem Description
A healthcare professional reported following an implantable collamer lens (icl) implantation procedure, the was exchanged for a longer length lens.Problem resolved.Additional information was requested.No further information is available at this time.This file will be re-opened if additional information is provided.
Additional Manufacturer Narrative
A3a - unk.A4 - unk.A5 - unk.A6 - unk.B3 - unk.Claim #: (b)(4).
Additional Manufacturer Narrative
Additional information/corrections: b5 - reported as a healthcare professional reported following an implantable collamer lens (icl) implantation procedure, the was exchanged for a longer length lens.Problem resolved.Additional information was requested.No further information is available at this time.This file will be re-opened if additional information is provided.- update to - a healthcare professional reported following an implantable collamer lens (icl) implantation procedure, the patient experienced a lens diameter being too small(low vault).The was exchanged for a longer length lens.Problem resolved.D6a - reported as (b)(6) 2022 - correct to (b)(6) 2023.D6b - reported as (b)(6) 2023 - correct to (b)(6) 2024.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC 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: 19702269
• Report Number: 2023826-2024-03003
• Device Sequence Number: 3701507
• Product Code: QCB
• UDI-Device Identifier: 00840311305643
• UDI-Public: 00840311305643
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 06/19/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: VTICM5_12.1
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2022
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown