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

Model Number	VICM5_12.6
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	07/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Correction data: b1 - reported as; product problem - correct to; adverse event.B2 - report as; required intervention to prevent permanent impairment/damage.H1 - reported as; malfunction - correct to: serious injury.Claim# (b)(4).
Event or Problem Description
A healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced excessive vault.Additional information was requested.No further information is available at this time.This file will be re-opened if additional information is provided.There are multiple medical device reports associated with this patient.This report is 1 of 2 total reports.Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.
Additional Manufacturer Narrative
A2 - unk, a3 - unk, a4 - unk, a5 - unk, a6 - unk, b3 - unk, d2 - unk, d4 - unk, d6a - unk, and h4 - unk.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: b5 - reported as; a healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced elevated iop 23mmhg without pupil block and angle closure, significant reduction of iridocorneal angles, glare/haloes, and excessive vault.Additional information was requested.No further information is available at this time.This file will be re-opened if additional information is provided.There are multiple medical device reports associated with this patient.This report is 1 of 2 total reports.Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.Correct to; a healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced elevated iop 23mmhg without pupil block and angle closure, significant reduction of iridocorneal angles, glare/haloes, and excessive vault.In a separate visit the lens was exchanged and the problem was resolved.Additional information was requested.No further information is available at this time.This file will be re-opened if additional information is provided.There are multiple medical device reports associated with this patient.This report is 1 of 2 total reports.Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.D6b - report as; 23-oct-2024 h6 - health effect - impact code (f): reported as; 2199 - correct to 4629 h6 - medical device problem code (a): reported as; 3189 - correct to 2993 h6 - type of investigation (b): report; 4110 claim# 434346 manufacturer narrative comment; device revision or replacement (lens replaced or exchanged) or reposition is identified in the labeling as a known potential adverse event following icl implantation.
Additional Manufacturer Narrative
Additional information: entered through out form.H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
A healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced elevated iop 23mmhg without pupil block and angle closure, significant reduction of iridocorneal angles, glare/haloes, and excessive vault.Additional information was requested.No further information is available at this time.This file will be re-opened if additional information is provided.There are multiple medical device reports associated with this patient.This report is 1 of 2 total reports.Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC 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: 20493990
• Report Number: 2023826-2024-04766
• Device Sequence Number: 4174428
• Product Code: MTA
• UDI-Device Identifier: 00840311300570
• UDI-Public: (01)00840311300570(11)240525(17)270430
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/04/2024

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: VICM5_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: 10/04/2024
• Supplement Date Received by Manufacturer: 10/22/2024; 12/19/2024; 01/16/2025
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 12/05/2024; 12/19/2024; 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2024
• 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
• Patient Age: 38 YR
• Patient Sex: Female