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

Model Number	VTICMO 13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated that a 13.2mm vticm5 13.2 implantable collamer lens of -8.00/1.0/055 (sphere/cylinder/axis) was implanted into the patients left eye (os) on (b)(6) 2023.Iris atrophy was reported.The patient is completely asymptomatic; pio and visual acuity is perfect.The lens remains implanted.Cause reported as unknown.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
H6: clinical code: 4581: iris atrophy.H6: investigation type 4110: lens work order search: no similar complaint event(s) within associated lots were found.Claim #: (b)(4).
Additional Manufacturer Narrative
B1 - corrected to: adverse event in the initial mdr.B2 - corrected to : required intervention to prevent permanent impairment/damage in the initial mdr.H1- corrected to : serious injury in the initial mdr.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
• MDR Report Key: 18773149
• Report Number: 2023826-2024-00806
• Device Sequence Number: 7701602
• Product Code: QCB
• UDI-Device Identifier: 00840311311149
• UDI-Public: 00840311311149
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2024

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: 06/30/2026
• Device Model Number: VTICMO 13.2
• 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: 01/25/2024
• Supplement Date Received by Manufacturer: 05/11/2024
• Initial Report FDA Received Date: 02/23/2024
• Supplement Report FDA Received Date: 05/11/2024
• Date Device Manufactured: 08/10/2023
• 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: INJECTOR MODEL: MSI-PF, LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR
• Patient Sex: Female