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

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	07/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that after implantable collamer lens (icl) implantation into the patient's eye, toxic anterior segment syndrome (tass) was diagnosed.No additional diagnostics were performed.Severity was not provided.Information regarding concomitant products used intraoperatively was not provided.In a separate visit treatment was performed of cleaning and lens removal.No further information is available at this time.If additional information is received, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
H6-investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.A review of the device labeling was completed.Corneal edema, iop above baseline, iritis and intraocular inflammation are identified in the labeling as known adverse events following icl implantation.The dfu states a warning: complete removal of viscoelastic from the eye after completion of the surgical procedure is essential.Viscoelastic instruments that may be difficult to inhale should not be used.The dfu states a warning: staar surgical icl and disposable accessories are packaged and sterilized for single use only.Cleaning, refurbishing and/or re-sterilization are not applicable to these devices.If one of these devices were reused after cleaning or refurbishing, it is highly probable that it would be contaminated, and the contamination could result in infection and/or inflammation.Toxic anterior segment syndrome (tass) is an acute sterile postoperative inflammation that can occur after uncomplicated or complicated intraocular surgery.While improper sterilization and contamination of surgical instruments remains the most common risk factor associated with tass, ocular viscoelastic, and improper preparation of antibiotics for intracameral injection may also lead to tass.The cause of the event was due to remnant of foreign matter in the eye and therefore is not device related.Claim#: (b)(4).
Additional Manufacturer Narrative
H3-inspection of the returned device analyzed six different particles by ftir and sem-edx.Their spectra were consistent with wax, sodium hyaluronate, phenoxy resin, two tialv alloys, and phosphate salt with organic material, respectively.The wax observed during particle analysis was present in quantities below the limit of detection of gc-ms.H6- investigation 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
Additional information: b5- it was reported that recovery was observed on day 122 post op.A replacement lens of unknown parameters was implanted.Post-op the ucva was recorded as 20/10 (better than pre-op bcva 20/20).Claim# (b)(4).

• 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 ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 20215007
• Report Number: 2023826-2024-04172
• Device Sequence Number: 8151820
• Product Code: MTA
• UDI-Device Identifier: 00840311300594
• UDI-Public: 00840311300594
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2024

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 Model Number: VICM5 12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 11/14/2024; 09/12/2025
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 12/03/2024; 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2023
• 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# UNK.; FOAM TIP PLUNGER (FTP), LOT# UNK.; INJECTOR MODEL: MSI-PF, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Female