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

Model Number	VTICM5_12.6
Medical Device Problem Codes	Off-Label Use (1494); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated that on (b)(6) 2023 a 12.6mm vticm5_12.6 implantable collamer lens of -12.0/2.5/094 (sphere/cylinder/axis) tore/broke before/during injection/delivery into the patients right eye (od).Intraoperatively the lens was removed and replaced and the problem resolved.
Additional Manufacturer Narrative
H6 - type of investigation - lens work.Order search: no similar complaint type events reported for units within the same lot, (b)(4).
Additional Manufacturer Narrative
Corrected data: h6 - medical device problem code 1494: off-label use (under 21 yrs of age at date of implantation) added to initial mdr.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 17778200
• Report Number: 2023826-2023-04111
• Device Sequence Number: 20293301
• Product Code: QCB
• UDI-Device Identifier: 00840311308705
• UDI-Public: 00840311308705
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023

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: 09/30/2025
• Device Model Number: VTICM5_12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2022
• 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 W/FTP, LOT# 1589907; FOAM TIP PLUNGER, LOT# 1589916; INJECTOR MODEL: MSI-PF, LOT# UNK
• Patient Age: 19 YR
• Patient Sex: Female