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

Model Number	VTICM5_12.1
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4 - unk, a5 - unk, a6 - unk, h6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.1mm vicm5 12.1, -10.5 diopter, implantable collamer lens from the patient's left eye (os) on (b)(6) 2023.The lens was removed on (b)(6) 2023.A longer length lens was implanted on (b)(6) 2023 due to low vault.This did not resolved the problem.Cause of the event is reported as unknown.Reportedly, lens size increased but low vault not resolved.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
Correction: a2: date of birth is unknown.Additional information: h3: device evaluation: the lens was returned dry in a microcentrifuge vial with residue/debris on the product.Visual inspection found haptic broken.Dimensional inspection found the lens to be within specifications.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 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: 18473814
• Report Number: 2023826-2024-00138
• Device Sequence Number: 6398410
• Product Code: MTA
• UDI-Device Identifier: 00840311300280
• UDI-Public: 00840311300280
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2023

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_12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2023
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male