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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - health effect clinical code 4581: significant reduction of irido-coneal angles h6 - work order search: no similar complaint type events were reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2, -9.5/3.5/091 (sphere/cylinder/axis), implantable collamer lens into the patient's right eye (od) on (b)(6)2024.Significant reduction of irido-corneal angles, and excessive vault were observed.Lens remains implnated.Cause of the event is reported as device.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
Additional information: b1 - reported as product problem - update to adverse event b2 - not reported - update to required intervention to prevent permanent impairment/damage d6b - not reported - update to (b)(6) 2024.H1 - reported as malfunction - update to serious injury.H6 - health effect - impact code(f) reported as 2199 - update to 4627.Claim# (b)(4).
Additional Manufacturer Narrative
D4 - primary unique device indentifier (udi)#:(b)(4) "udi related data quality updates only".H3 - device evaluation: lens was returned in micro-centrifuge vial, in liquid, residue/debris on product.Visual inspection found no visible damage to lens.Dimensional inspection found the lens to be within specifications.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: 19613807
• Report Number: 2023826-2024-02737
• Device Sequence Number: 6954615
• Product Code: QCB
• UDI-Device Identifier: 00840311312573
• UDI-Public: (01)00840311312573(11)240223(17)270131(21)T1899750
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 07/03/2024; 10/08/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/11/2024; 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• 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.; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK.
• Patient Age: 50 YR
• Patient Sex: Female