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

Model Number	VICM5 12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	04/28/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4-a6: unk.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
The reporter indicated that the surgeon implanted a 12.6mm vicm5 -13.00d implantable collamer lens into the patient's right eye (od) on (b)(6) 2024.Concomitant products used intraoperatively include opegan viscoelastic and the msi injector system.Toxic anterior segment syndrome (tass) was diagnosed.No diagnostic tests were performed.In the reporter's opinion, the cause was unknown with "many inflammatory cells on the back surface of the lens".Steroid and pupil dilating eyedrops were prescribed and a "rinsing" was performed.Additional anterior chamber irrigation and evacuation of visco/fluids was performed.The lens was explanted next day (day 1).Last report on day 4 states that residual pigmentation is improving with replacement lens surgery pending.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
Additional information: 4112- inspection of the returned device identified a foreign particulates on the lens.External laboratory analysis was performed to determine the composition of the foreign material identified on the lens.The particles were found to be primarily composed of protein with lens material and trace amounts of sodium, phosphorus, calcium, sulfur, chloride, magnesium, and aluminum for particle 1.Particle 2 was primarily composed of a fatty amide.Particle 3 was primarily composed of protein and phosphate salts (mostly calcium) with trace amounts of magnesium, chloride, silicone, aluminum, and sulfur.H6: 3331-device history review: the device history records were reviewed and there were no non-conformities or deviations noted during the manufacturing of the lens that would have caused or contributed to the nature of this complaint.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.Corrective and/or preventive actions are being addressed through capa-24-001 and this issue will continue to be tracked and trended as part of the normal device safety committee meetings and capa monitoring.Cllaim#(b)(4).
Additional Manufacturer Narrative
Additional information: b5 - symptoms appeared the day after surgery (visual acuity 20/29); a fibrin membrane covered the pupillary area, and the anterior chamber was irrigated.During irrigation, inflammation on the posterior surface of the icl appeared to spread throughout the eye; 30 minutes later, fibrin redeposited, and the icl was removed.Inflammation subsided the following day.One week later, almost no anterior chamber inflammation was observed.Corrected visual acuity was good.The icl was reinserted on may 30.Uncorrected visual acuity is 20/13'.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS, PRODUCT CODE: MTA
• 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 ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 19388146
• Report Number: 2023826-2024-02210
• Device Sequence Number: 4020178
• Product Code: MTA
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Model Number: VICM5 12.6
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 07/11/2024; 05/20/2026
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 07/11/2024; 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2023
• 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: CARTRIDGE MODEL: SFC-45, LOT#1719899; FOAM TIP PLUNGER (FTP), LOT#1710858; INJECTOR MODEL: MSI-PF, LOT#1591457
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Unknown