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

Model Number	VTICM5 13.7
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: b5-the reporter indicated that a 13.7mm vicm5 13.7 implantable collamer lens of -8.50/1.0/103 (sphere/cylinder/axis) got caught in a msi-pf injector; lot #1658879 on (b)(6) 2024.The lens was implanted, removed and replaced intra-operatively on (b)(6) 2024.The replacement lens resolved the problem.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 13.7mm vicm5 13.7 implantable collamer lens of -8.50/1.0/103 (sphere/cylinder/axis) got caught in a msi-pf injector; lot #1658879 on an unknown date.Reportedly the lens had patient contact but the lens was not fully implanted.A backup lens of the same model, size and similar power was implanted and the problem was resolved.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
H6-investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.(b)(4).
Additional Manufacturer Narrative
H6- method code 3331: device history record (dhr) review: based on the results of the investigation, all released devices from the associated work orders(s), including the suspected device, have been manufactured within established 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: 18926909
• Report Number: 2023826-2024-01197
• Device Sequence Number: 4580188
• Product Code: QCB
• UDI-Device Identifier: 00840311314515
• UDI-Public: 00840311314515
• 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 Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2024

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 Model Number: VTICM5 13.7
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/01/2024; 05/31/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 05/07/2024; 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2024
• 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: INJECTOR MODEL: MSI-PF, LOT# 1658879
• Patient Sex: Unknown