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

Model Number	TMICL 12.1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cataract (1766); Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6- investigation type code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.H6-health impact code: 4625- 'prk' was performed.(b)(4).
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced residual astigmatism.In a separate visit prk was performed and the problem was resolved.The cause of the event was reported as other, and the device did not fail to perform as intended.Cause details provided: "surgeon reports unrelated to device but related to procedure".
Additional Manufacturer Narrative
Additional data: b3.- "11/09/2023" should be removed and "04/08/2025" should be added.B5.- a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced low vault, residual astigmatism, glares/haloes and an asc opacity was observed.In a separate visit prk was performed.The lens remains implanted.Reportedly, "plan to switch from icl to evo icl".The cause of the event was reported as unknown.H6.- health effect - clinical code (e): 1766/ 2227/ 2140 should be added.H11.- manufacturer narrative: cataract, significant glare and/or halos is identified in the labeling as a known potential adverse event following icl implantation.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: b5.- a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced low vault, residual astigmatism, over/under correction, glares/haloes and an asc opacity was observed.In a separate visit prk was performed.Reportedly, "plan to switch from icl to evo icl".In a separate surgery the lens was exchanged with a different model, longer length.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.D6b.- (b)(6) 2025 should be added.H6.- health effect - impact code (f): 4629 should be added.Corrected data: health effect- clinical code (e): '4581- over/under correction' should be added.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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 21154297
• Report Number: 2023826-2025-00105
• Device Sequence Number: 13035976
• Product Code: QCB
• UDI-Device Identifier: 00841542105026
• UDI-Public: (01)00841542105026(17)220930
• 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: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: TMICL 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: 01/09/2025
• Supplement Date Received by Manufacturer: 07/24/2025; 11/13/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 08/01/2025; 12/01/2025
• Date Device Manufactured: 10/20/2020
• 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.; INJECTOR MODEL: LIOLI-24, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Female