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

Model Number	VTICM5 13.2
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 13.2 vticm5 13.2 implantable collamer lens of -9.00/1.5/118 (sphere/cylinder/axis) was implanted into the patients right eye (od) on (b)(6) 2024.Excessive vault has been reported.The lens currently remains implanted.No further information has been provided.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
H6-investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: b1-adverse event.B2-required intervention to prevent permanent impairment/damage (devices) b5-a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced an excessive vault.In a separate visit the lens was exchanged for a shorter length lens and the problem was resolved.This report is 1 of 2 total reports.Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.D6b- on (b)(6) 2024.Corrected data: d4- model# is vticm5 13.2.(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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 19524840
• Report Number: 2023826-2024-02515
• Device Sequence Number: 15556603
• Product Code: QCB
• UDI-Device Identifier: 00840311311446
• UDI-Public: 00840311311446
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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
• Report Date (Section B): 05/15/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: VTICM5 13.2
• 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: 05/15/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female