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

Model Number	VTICM5_12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - health effect clinical code 4581: pigment dispersion.H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).Manufacturer narrative - manufacturer narrative - iritis and pigment dispersion are identified in the labeling as known potential adverse events following icl implantation.The dfu states for complications and adverse reactions: adverse reactions and complications due to, or following surgery and implantation of any evo/evo+ ticl may include, but are not limited to: hyphema, non-reactive pupil, pupillary block, additional yag iridotomy, secondary glaucoma, cataract, intraocular infection, uveitis/iritis, retinal detachment, vitritis, corneal edema, macular edema, corneal decompensation, over/under correction, significant glare and/or halos (under night driving conditions), hypopyon, increased astigmatism, loss of bscva, rotation/decentration/ subluxation, iop elevation from baseline, corneal endothelial cell loss, iris pigment dispersion, secondary surgical intervention to remove/replace/ reposition the lens, peripheral anterior synechia (pas), iris synechia to implant, conjunctival irritation, vitreous loss a precaution provided: (7) safety and effectiveness of the lens has not been established in patients with: unstable refractive error in either eye, keratoconus, history of clinical signs of iritis/uveitis, synechia, pigment dispersion syndrome, pseudoexfoliation, insulin-dependent diabetes or diabetic retinopathy, history of previous ocular surgery including refractive corneal surgery.In cases of episodic or recurrent inflammation, patient anatomy, systemic health and autoimmune factors are potential contributors.An exact cause could not be determined as the event could be multifactorial in nature including patient and procedural factors.
Event or Problem Description
A staar representative was contacted by the implanting surgeon who forwarded a report of a vticm5 toric implantable collamer lens implanted into the patient's left eye (os) on (b)(6) 2023.This lens was explanted on (b)(6) 2024.Pigment dispersion and recurrent iritis were observed prior to explantation.Visual acuity and iop parameters were not provided, as well as the cause of the event.The surgeon reported the patient refused to undergo "surgery (replacement of lens)".Reportedly the fellow eye is quiet with an icl implanted.To date the lens has not been returned for evaluation.If additional information is received, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
D4 - primary unique device indentifier (b)(4) "udi related data quality updates only".H6- device history record (dhr) review; the dhr review indicates 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.Corrective and/or preventative 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.Claim# (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
• MDR Report Key: 20235475
• Report Number: 2023826-2024-03873
• Device Sequence Number: 8043035
• Product Code: QCB
• UDI-Device Identifier: 00840311309559
• UDI-Public: (01)00840311309559(11)221117(17)251031(21)T1251657
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 08/23/2024

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: 10/31/2025
• Device Model Number: VTICM5_12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2023
• 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; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK; INJECTOR MODEL#MSI-PF,LOT#UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female