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

Model Number	VTICM5 12.1
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	05/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Claim (b)(4).
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced lens rotation with lens dislocation/subluxation.In a separate visit the lens was repositioned.In a third visit the lens was exchanged for a longer length lens.The problem was resolved.Cause of the event was reported as unknown.No additional similar complaint types were within associated lots were found.Per the medical review this claim is deemed as serious with unknown device causality.This issue will continue to be tracked and trended as part of the normal dsc meetings and capa monitoring.If a significant trend is identified, then the issue will be escalated for further action.
Additional Manufacturer Narrative
E1 (b)(6).E2 yes.E3 physician.H3 - type of investigation code: 10- device evaluation: the lens was returned in liquid within a vial.Visual inspection found no visible damage to the lens.Dimensional inspection found the lens to be outside of original values.H6- investigation type code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.
Additional Manufacturer Narrative
Additional information: h6- method code 3331: device history record (dhr) review: based on the results of the investigation, all released devices from the associated work orders(s), including the suspected device, have been manufactured within established parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Claim# (b)(4).
Additional Manufacturer Narrative
Corrected data: d9 in supplemental mdr# 1 should include date 03-feb-2025.H2 in supplemental mdr#1 should also indicate device evaluation.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 ; 800 royal oaks dr.; suite: 210; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 21210420
• Report Number: 2023826-2025-00142
• Device Sequence Number: 8156701
• Product Code: QCB
• UDI-Device Identifier: 00840311304806
• UDI-Public: (01)00840311304806(11)240102(17)261231
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/31/2024

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?: No
• Device Model Number: VTICM5 12.1
• 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: 12/31/2024
• Supplement Date Received by Manufacturer: 03/25/2025; 06/03/2025; 06/05/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 04/23/2025; 06/04/2025; 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL-SFC-45, LOT# UNK.; FOAM TIP PLUNGER MODEL-FTP, LOT# UNK.; INJECTOR MODEL-MSI-PF, LOT# UNK.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR
• Patient Sex: Female