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	08/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6-investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.Claim#: (b)(4).
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced an excessive vault.The lens remains implanted.The patient is being monitored.If additional information is received, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Corrected data; g4 premarket identification in previous mdr should be corrected to pma/510(k): p030016; device bla is unk.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: 20262207
• Report Number: 2023826-2024-04361
• Device Sequence Number: 8722773
• Product Code: QCB
• UDI-Device Identifier: 00840311311828
• UDI-Public: (01)00840311311828(11)240424(17)270331
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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 13.2
• 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: 08/28/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2024
• 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: CARTRIDGE MODEL: SFC-45: LOT# 1761503; FOAM TIP PLUNGER (FTP), LOT# 1719033; INJECTOR MODEL: MSI-PF, LOT# 1583699
• Patient Age: 26 YR
• Patient Sex: Female