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

Model Number	VTICM5 12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced low vault.In a separate visit the lens was exchanged for a longer length lens and the problem was resolved.It has been noted that the surgeon elected a different length lens than that initially suggested by the icl calculation software.Therefore, there is not enough safety and effectiveness data to support implantation in this patient category.Cause of the event was reported as unknown.There are multiple medical device reports associated with this patient.This is report 2 of 2 total reports.Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause of contribution of the reported issue is not indicative of a manufacturing related issue of product.Deficiency.
Additional Manufacturer Narrative
Claim# (b)(4).See claim# (b)(4), for fellow eye.
Additional Manufacturer Narrative
B5 - corrected to: "a healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced low vault.In a separate visit the lens was exchanged for a longer length lens and the problem was resolved.Cause of the event was reported as unknown.There are multiple medical device reports associated with this patient.This is report 1 of 2 total reports.Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause of contribution of the reported issue is not indicative of a manufacturing related issue of product deficiency." in the initial mdr.Claim # (b)(4).
Event or Problem Description
A healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced low vault.In a separate visit the lens was exchanged for a longer length lens and the problem was resolved.Cause of the event was reported as unknown.There are multiple medical device reports associated with this patient.This is report 1 of 2 total reports.Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause of contribution of the reported issue is not indicative of a manufacturing related issue of product deficiency.

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS, PRODUCT CODE: QCB
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia 91016
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 800 royal oaks dr. suite:210; monrovia, CA 91016
• MDR Report Key: 20201944
• Report Number: 2023826-2024-04260
• Device Sequence Number: 20716707
• Product Code: QCB
• UDI-Device Identifier: 00840311308941
• UDI-Public: 00840311308941
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2024

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: 07/31/2026
• Device Model Number: VTICM5 12.6
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 12/07/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 12/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2023
• 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-UNK.; FOAM TIP PLUNGER MODEL-UNK.; INJECTOR MODEL-UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female