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

Model Number	VTICM5_12.6
Medical Device Problem Codes	Misfocusing (1401); Off-Label Use (1494)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	11/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 12.6mm vticm5_12.6 implantable collamer lens of -5.00/2.00/006 (sphere/cylinder/axis) was implanted into the patient's right eye (od) on (b)(6) 2023.On (b)(6) 2023 the lens was explanted and later replaced with a different power lens due to refractive surprise.It was reported that the problem resolved.Patient-related factor was reported to be the cause of the event.However, it was reported that the lens did not fail to perform as intended.
Additional Manufacturer Narrative
H6 - type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).
Additional Manufacturer Narrative
Device evaluation: h3: type of investigation code: 10- device evaluation: the lens was returned in a microcentrifuge vial with liquid and residue/debris on the product.Visual inspection found no visible damage.Dimensional and functional inspection found the lens to be within specifications.Corrected data: h6: medical device problem code: "1494- off label use (pre existing: keratoconus)" should be added.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 ; 6263037902
• MDR Report Key: 18505077
• Report Number: 2023826-2024-00118
• Device Sequence Number: 18164529
• Product Code: QCB
• UDI-Device Identifier: 00840311308286
• UDI-Public: 00840311308286
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2023

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_12.6
• 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: 12/18/2023
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2023
• 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 W/FTP, LOT# UNK.; INJECTOR MODEL: MSI-TF, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male