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

Model Number	VTICM5_12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6; -13.0/1.5/164 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6)2023.The surgeon reports there is tass and additionally reported - fibrin, strong flares, adhesive around eye, medication used.The surgeon reports there will be not additional intervention as the symptoms have resolved.Lens remains implanted.
Additional Manufacturer Narrative
H6 - health effect clinical code: 4581 - fibrin, strong flares, adhesive around eye.H6 - type of investigation: 4110 lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).
Additional Manufacturer Narrative
H6: 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.Corrective and/or preventive actions are being addressed through capa: 24-001 and this issue will continue to be tracked and trended as part of the normal device safety committee meetings and capa monitoring.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 ave; monrovia, CA 91016
• MDR Report Key: 18547783
• Report Number: 2023826-2024-00308
• Device Sequence Number: 12993278
• Product Code: QCB
• UDI-Device Identifier: 00840311308163
• UDI-Public: 00840311308163
• 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
• 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): 01/09/2024

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 Model Number: VTICM5_12.6
• 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: 01/09/2024
• Supplement Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2023
• 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.; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK.; INJECTOR MODEL-MSI-PF, LOT#-UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Unknown