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

Model Number	MICL 13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Claim: (b)(4).See claim: (b)(4) for fellow eye.
Event or Problem Description
Dl a healthcare representative reported following an implantable collamer lens (icl) implantation procedure, the patient experienced residual refractive error, intermittent angle closure with elevated iop.The lens remains implanted.Cause reported as patient related factor.
Additional Manufacturer Narrative
B5: a healthcare representative reported following an implantable collamer lens (icl) implantation procedure, the patient experienced refractive change overt time, intermittent angle closure with elevated iop.The lens was exchanged for a shorter length lens.Cause of the event was reported as patient related factor.There are multiple medical device reports associated with this patient.This is report 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.It should be noted that the surgeon selected a different lens size than that suggested by the icl software.Therefore, there is not enough safety and effectiveness data to support implantation in this patient category.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.D6b: (b)(6) 2025, d9: 19-mar-2025, e1: (b)(6), e2: health professional, e3: physician, g3: 19-feb-2025.H6: 2137 blurred vision; 4629 device replacement.Claim (b)(4).See claim (b)(4) for fellow eye.
Event or Problem Description
A healthcare representative reported following an implantable collamer lens (icl) implantation procedure, the patient experienced refractive change overt time, intermittent angle closure with elevated iop.The lens was exchanged for a shorter length lens.Cause of the event was reported as patient related factor.There are multiple medical device reports associated with this patient.This is report 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.It should be noted that the surgeon selected a different lens size than that suggested by the icl software.Therefore, there is not enough safety and effectiveness data to support implantation in this patient category.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
B5: a healthcare representative reported following an implantable collamer lens (icl) implantation procedure, the patient experienced refractive change over time, intermittent angle closure with elevated iop.The lens was exchanged for a shorter length lens.Cause of the event was reported as patient related factor.There are multiple medical device reports associated with this patient.This is report 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.Visian icl is contraindicated for those less than 21 years of age.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.Claim (b)(4).See claim (b)(4) for fellow eye.

• 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 ; 800 royal oaks dr.; suite: 210; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 21370038
• Report Number: 2023826-2025-00242
• Device Sequence Number: 8482346
• Product Code: MTA
• UDI-Device Identifier: 00841542103299
• UDI-Public: (01)00841542103299(17)190731
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2025

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 Expiration Date: 07/31/2019
• Device Model Number: MICL 13.2
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 02/19/2025; 05/08/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 04/14/2025; 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2017
• 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: 27 YR
• Patient Sex: Female