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

Model Number	VTICM5_12.1
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Date of Event	11/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11 - manufacturer narrative: iop elevation from baseline, pigment dispersion, is identified in the labeling as a known potential adverse event following icl implantation.(b)(4).
Event or Problem Description
A health care professional reported that an implantable collamer lens was implanted into the patient's eye.The patient experienced excessive vault and elevated iop and pigment dispersion.Lens remains implanted.Cause of event is reported as unknown.
Additional Manufacturer Narrative
B5 - a health care professional reported that an implantable collamer lens was implanted into the patient's eye.The patient experienced elevated iop and pigment dispersion.Lens remains implanted.Cause of event is reported as unknown.Claim # (b)(4).
Additional Manufacturer Narrative
B5 - a health care professional reported that an implantable collamer lens was implanted into the patient's eye.The patient experienced elevated intraocular pressure (lop), pigment dispersion glaucoma, and blurred vision.Medication was given.The cause of the event was reported as unknown.To the best of our knowledge, the lens remains implanted.H6- investigation type 4110: lens work order search-no similar complaints reported for units within the same lot.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: 20242237
• Report Number: 2023826-2024-04375
• Device Sequence Number: 18176390
• Product Code: QCB
• UDI-Device Identifier: 00840311305360
• UDI-Public: (01)00840311305360(11)230303(17)260228
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: VTICM5_12.1
• 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: 08/28/2024
• Supplement Date Received by Manufacturer: 09/17/2024; 12/07/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 09/17/2024; 12/08/2024
• Date Device Manufactured: 03/03/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21 YR
• Patient Sex: Male