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

Model Number	VICM5_13.2
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	12/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - type of investigation: 4110 - lens work order search: one similar complaint type events reported for units within the same lot.Manufacturer narrative: secondary surgical intervention to remove/replace/reposition the lens, is identified in the labeling as a known potential adverse event following icl implantation.Precaution (6) after inserting this product, aspirate the viscoelastic substance completely from inside the eye.Do not use highly viscous viscoelastic substances that are difficult to aspirate completely.Opegan was used during the procedure and is a viscous cohesive of purified sodium hyaluronate manufactured by seikagaku.Per the delivery system dfu: sterilization instructions: after the injector has been properly cleaned, the injector should be pouched to preserve sterility and steam sterilized using the following sterilization cycle: (note: the microstaar injector models msi-tf and msi-pf can be cleaned and sterilized up to 20 times before disposal).Warning staar surgical cartridges, ftps and ftp holders are packaged and sterilized for single use only.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 handpiece (which is a reusable instrument) was used.An exact cause could not be determined as the event could be multifactorial in nature including patient and/or procedure related factors.Claim# (b)(4).
Event or Problem Description
A facility representative reported that an implantable collamer lens was implanted into the patient's eye on (b)(6) 2024.Concomitant products used intraoperatively include the msi delivery system with sfc-45 with ftp and opegan ovd.Treatment and diagnostics were not performed.The lens was explanted and later replaced with a same length and power lens but the problem was not resolved.It is noted the with the initial lens that the patient is under observation, tass occurred after operation.The lens was removed at a different clinic.
Additional Manufacturer Narrative
Corrected data: b5 - the reporter indicated an implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2024 and explanted on day 4 at a different clinic.The patient underwent bilateral sequential surgery.Concomitant products used intraoperatively include the msi delivery system with sfc-45 with ftp and opegan ovd.Tass and endophthalmitis were reported with no diagnostics performed.The reporter does not provide information neither of causality nor medication used for treatment.Additional information is stating that "tass occurred after operation, but since (b)(6) was closed, the lens was removed at (b)(6).To avoid such situation, it is requested that the company takes action to address the causes and countermeasures and shows its stance".A replacement lens of the same length and power was implanted on (b)(6) 2024.At the last report of (b)(6) 2024, the patient remains under observation as the issue is unresolved.If additional information is received a supplemental medwatch report will be submitted.Manufacturer narrative: a review of the device labeling was completed.Intraocular infection, iritis/iridocyclitis and lens extraction/reinsertion are identified in the labeling as known potential adverse events following icl implantation.The dfu states precautions to physicians (10) this product should not be immersed in anything other than commonly used intraocular irrigation fluids or viscoelastic substances.Precaution: (6) after inserting this product, aspirate the viscoelastic substance completely from inside the eye.Do not use highly viscous viscoelastic substances that are difficult to aspirate completely.Opegan was used during the procedure and is a viscous cohesive of purified sodium hyaluronate manufactured by (b)(4).Per the delivery system dfu: sterilization instructions: after the injector has been properly cleaned, the injector should be pouched to preserve sterility and steam sterilized using the following sterilization cycle: (note: the microstaar injector models msi-tf and msi-pf can be cleaned and sterilized up to 20 times before disposal).Warning staar surgical cartridges, ftps and ftp holders are packaged and sterilized for single use only.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.In some cases, a prolonged or persistent inflammation suggests secondary systemic health, ocular issues or issues with the post-op medication regimen.To date, there is no confirmation of identified microorganisms.An exact cause could not be determined as the event could be multifactorial in nature including patient and/or procedure related factors.Claim#: (b)(4).
Additional Manufacturer Narrative
H6 - type of investigation 3331 - device history record (dhr) review: 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.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker ave; monrovia, CA 91016
• MDR Report Key: 21164185
• Report Number: 2023826-2025-00117
• Device Sequence Number: 21199342
• Product Code: MTA
• UDI-Device Identifier: 00840311300891
• UDI-Public: (01)00840311300891(11)240325(17)270228
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/25/2024

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_13.2
• 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: 12/25/2024
• Supplement Date Received by Manufacturer: 01/16/2025; 02/04/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 01/16/2025; 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2024
• 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: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male