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

Model Number	VTICM5_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	05/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4: unk.A5: unk.A6: unk.H6: health effect - impact code (f): additional medications: 4644 - steroid; moxifloxacin drops.H6 - work order search: no similar complaint was reported for units within the same lot.H11: manufacturer narrative: a review of the device labeling was completed.Iritis and intraocular infection are identified in the labeling as known potential adverse event following icl implantation.Adverse events include but are not limited to: intraocular infection and secondary surgical intervention to remove/replace the lens.The dfu provides the surgeon instruction for complete ovd removal.Warning: completely remove viscoelastic from the eye after completion of the surgical procedure.A low molecular weight 2% hydroxypropyl methylcellulose (hpmc) or dispersive, low viscosity ophthalmic viscosurgical device is recommended.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.Given the bilateral and delayed presentation, 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 following the implant of an implantable collamer lens into the patient's eye, toxic anterior segment syndrome (tass) was diagnosed bilaterally.The patient underwent bilateral sequential surgery.Per the reporter this occurred in the same surgery room with different instrument sets.Information about ovd and the lens delivery system were not provided.Intracameral moxifloxacin hydrochloride/ loteprednol etabonate / ofloxacin were used.Diagnostic culture was not performed.The patient was prescribed standard steroid and moxifloxacin drops for two weeks after surgery.The lens was removed, and the problem was resolved.Per post-op visit, patient condition was bcva: 20/20; iop: 11 mmhg.The reporter does not provide a cause for the event.Additional information has been requested but none has been forthcoming.There are multiple 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.
Additional Manufacturer Narrative
H6: device history record (dhr) review: the dhr review indicated that the product has been manufactured within the established process parameters and that there is no indication that the manufacturing and/or processing of the device contributed to the complaint issue.(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 muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 20294367
• Report Number: 2023826-2024-04211
• Device Sequence Number: 8086672
• Product Code: QCB
• UDI-Device Identifier: 00840311311934
• UDI-Public: (01)00840311311934(11)240108(17)261231
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 08/30/2024

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: VTICM5_13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: 11/17/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/08/2024
• 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: UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Male