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

Model Number	VTICM5 12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported following an implantable collamer lens (icl) implantation procedure, the patient experienced endothelial trauma and refractive treatment was performed.The lens was removed intraoperatively.It has been noted that the surgeon selected a different lens size 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.The cause of the event was unknown.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
H6: 4581-endothelial cell trauma.H6 - work order search: no additional similar complaint within associated lots was found.Claim#(b)(4).
Additional Manufacturer Narrative
B5 reportedly, "focal trauma in a young patient without previous corneal pathology, usually it should resolve without treatment.In spain we do not have experience wit rho kinase inhibitors.I would simply try with corticosteroids 1 month and observe evolution.I have sent patient prescription for steroids." should be added in the initial mdr.(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• 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: 19745087
• Report Number: 2023826-2024-02846
• Device Sequence Number: 6532759
• Product Code: QCB
• UDI-Device Identifier: 00840311308309
• UDI-Public: 00840311308309
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/15/2024

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?: No
• Operator of Device: Health Professional
• 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: 06/19/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 11/10/2024
• Date Device Manufactured: 04/04/2024
• 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, LOT# UNK.; FOAM TIP PLUNGER (FTP), LOT# UNK.; INJECTOR MODEL: UNK, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Unknown