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

Model Number	VTICM5_12.6
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that a vial with a 12.6mm, vticm5_12.6, -9.0/1.5/069 (sphere/cylinder/axis), implantable collamer lens had whiteish powder on the vial and the lens was implanted into the patient's eye.The lens remains implanted.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
H3 - device evaluation: white residue on the vial.No lens was returned.The lens vial was not opened in product evaluations lab.H6 - type of investigation 3331 - device history record (dhr) review: the dhr review indicates that the product has not been manufactured within the established process parameters and that there is indication that the manufacturing and/or processing of the device contributed to the complaint issue.Claim #: (b)(4).
Additional Manufacturer Narrative
B5: upon further review, it has been determined that the event is not mdr reportable.There has been no report of serious injury or malfunction.Initial mdr is not applicable.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 JAPAN INC.; 1-1-1 nishi shimbashi; minato-ku, 105-0 003; JA 105-0003
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 18979472
• Report Number: 2023826-2024-01237
• Device Sequence Number: 6279930
• Product Code: QCB
• UDI-Device Identifier: 00840311308088
• UDI-Public: 00840311308088
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: VTICM5_12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: 05/03/2024; 02/07/2025
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 06/24/2024; 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2023
• 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: UNK.
• Patient Sex: Unknown