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

Model Number	VTICM5_13.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that a 13.2mm vticm5_13.2, -6.5/1.0/171 (sphere/cylinder/axis) implantable collamer lens for patient's left eye (os) damaged during lens setting on (b)(6) 2023.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
Work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
Additional Manufacturer Narrative
B3 - date of event: 19-aug-2023 corrected in initial mdr.B5 - the reporter indicated that a 13.2mm vticm5_13.2, -6.5/1.0/171 (sphere/cylinder/axis) implantable collamer lens for patient's left eye (os) damaged during lens setting on (b)(6) 2023.No patient contact or injury.Cause was reported as device with cause details written as "the lens was damaged when it was retracted during setting".Claim # (b)(4).
Additional Manufacturer Narrative
H6 - type of investigation 3331 - device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 17862031
• Report Number: 2023826-2023-04066
• Device Sequence Number: 5704717
• Product Code: QCB
• UDI-Device Identifier: 00840311311118
• UDI-Public: 00840311311118
• 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): 01/08/2024

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: 04/30/2026
• Device Model Number: VTICM5_13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• 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: 09/12/2023
• Supplement Date Received by Manufacturer: 11/09/2023; 01/04/2024
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 11/09/2023; 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2023
• 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,LOT#UNK.; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK.; INJECTOR MODEL#MSI-PF,LOT#UNK.
• Patient Age: 36 YR
• Patient Sex: Female