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

Model Number	VICM5 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	03/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6- health effect- clinical code 4581: heaviness in the eye.H6 type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm vicm5_12.6 implantable collamer lens of -6.00 diopter was implanted into the patient's right eye (od) on (b)(6) 2024.The reporter states that after icl implant the patient felt heaviness in the eye and had the lens explanted on (b)(6) 2024, problem resolved.Cause of event is unknown.
Additional Manufacturer Narrative
H6- device evaluation: lens was returned with moisture and residue/debris on product, in microcentrifuge vial.Visual inspection found no visible damage to lens.Debris was observed on the lens.Claim # (b)(4).
Additional Manufacturer Narrative
H6- device history record (dhr) review: based on the results of the investigation, the dhr review indicates that the product has been manufactured within the established process parameters and there is no indication that the manufacturing and/or processing of the device contributed to the complaint issue.Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC 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 ; 6263037902
• MDR Report Key: 19217974
• Report Number: 2023826-2024-02017
• Device Sequence Number: 7025999
• Product Code: MTA
• UDI-Device Identifier: 00840311300525
• UDI-Public: 00840311300525
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 04/05/2024

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: VICM5 12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 05/30/2024; 09/03/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 07/11/2024; 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2023
• 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: SFC-45 W/FTP, LOT# UNK.; INJECTOR MODEL: MSI-PF, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female