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

Model Number	VICM5_12.1
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	07/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - work order search: no additional similar complaint type events within associated lots were found.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.An exact cause could not be determined as the event could be multifactorial in nature including patient and/or procedure related factors.Secondary surgical intervention to remove/replace/reposition the lens is identified in the labeling as a known potential adverse event following icl implantation.Claim # (b)(4).
Event or Problem Description
A health care professional reported that during an implantable collamer lens (icl) implantation procedure, the patient experienced toxic anterior segment syndrome (tass).The lens remains implanted.Bilateral sequential surgery was performed.Betarnethasone valerate gentamicin sulfate 0.1% changed from 4 times to 6 times.The problem was resolved.Cause of event was reported as unknown.
Additional Manufacturer Narrative
B5 - a health care professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced toxic anterior segment syndrome (tass).The lens remains implanted.There was no abnormalities in vision or symptoms though minor fibrin is identified.The patient used ophthalmic solutions/drops (artificial tears) prior or after the surgery specifically levofloxacin hydrate eye drops from 3 days prior to surgery.Treatment that was performed was bilateral sequential surgery.Betarnethasone valerate gentamicin sulfate 0.1% changed from 4 times to 6 times.The problem was resolved.Cause of event was reported as unknown.Manufacturer narrative toxic anterior segment syndrome (tass) is identified in the labeling as a known potential adverse event following icl implantation.The evo/evo+ icl directions for use (dfu) states under adverse events: as with implantation of other types of intraocular lenses, potential adverse events can include, but are not limited to infection and iritis.The dfu provides the surgeon instruction for complete ovd removal.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.Claim #(b)(4).
Additional Manufacturer Narrative
D4 - primary unique device identifier (udi) #: (b)(4).H4 - device manufacture date: 01-feb-2024.Corrected to 21-feb-2024.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 INTAOCULAR 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: 19851930
• Report Number: 2023826-2024-03337
• Device Sequence Number: 12401315
• Product Code: MTA
• UDI-Device Identifier: 00840311300174
• UDI-Public: (01)00840311300174(11)240121(17)261231
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2024

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 Model Number: VICM5_12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2024
• Supplement Date Received by Manufacturer: 08/20/2024; 10/22/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 08/21/2024; 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2024
• 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, LOT # UNK; INJECTOR MODEL-MSI-PF, LOT # UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Unknown