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

Model Number	VTICM5 13.2 (-14.0/1.0)
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: type of investigation: 4110 - lens work order search: no similar complaint type events 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 lens rotation not associated to a low vault.The lens remains implanted.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.Cause of the event was reported as unknown.
Event or Problem Description
A healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced lens rotation and blurred vision.The lens was repositioned, and then exchanged for a different model lens of the same length.Additional notes reported, "lri performed at time of implantation." cause of event was reported as device and patient related factor.
Additional Manufacturer Narrative
Corrected data: a1: patient identifier: kt, a2: date of birth: on (b)(6) 1988, a3a: sex: male, d4: model#: vticm5 13.2 (-14.0/1.0), catalog#: vticm5 13.2, serial#: (b)(6), primary unique device identifier (udi) #: (b)(4), g2: report source: health professional.Additional information: b1: adverse event.B2: required intervention to prevent permanent impairment/damage.B5: describe event or problem: a healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced lens rotation and blurred vision.The lens was repositioned, and then exchanged for a different model lens of the same length.Additional notes reported, "lri performed at time of implantation." cause of event was reported as device and patient related factor.D6b: if explanted, give date: on (b)(6) 2025.H1: type of reportable event: serious injury.H6: health effect - clinical code (e): 2137.H6: health effect - impact code (f): 4629.H6: medical device problem code (a): 2993.Claim#: (b)(4).
Additional Manufacturer Narrative
H6 - type of investigation 3331 - 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.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 20539204
• Report Number: 2023826-2024-04931
• Device Sequence Number: 20887627
• Product Code: QCB
• UDI-Device Identifier: 00841542117135
• UDI-Public: (01)00841542117135(11)230311(17)250228
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2024

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: 02/28/2025
• Device Model Number: VTICM5 13.2 (-14.0/1.0)
• Device Catalogue Number: VTICM5 13.2
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: 11/17/2025; 01/05/2026
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 12/11/2025; 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2023
• 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: LIOLI-24 - LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male