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	08/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A reporter indicated that following the implant of a vicm5 13.2 -7.0 implantable collamer lens into the patient's right eye (od) on (b)(6) 2024.Concomitant products used intraoperatively include opegan and the msi injector delivery system.Toxic anterior segment syndrome (tass) was diagnosed.Bacteriological examination was performed and culture identification was negative.A treatment of anterior chamber cleaning + lens extraction was performed.On (b)(6) 2024 the lens was exchanged with a same model, length, and different power.Problems resolved.The cause of the event was unknown.Reportedly, there was pigment adhesion to the lens, but this was corrected by replacing the lens.
Additional Manufacturer Narrative
A4 - unk a5 - unk a6 - unk h6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).Manufacturer narrative comment; 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.
Additional Manufacturer Narrative
H6 device history record (dhr) review; 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 preventive 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.(b)(4).
Additional Manufacturer Narrative
Correction data: d4 - primary unique device indentifier (uid)# - reported as: (b)(4) - correct to: (b)(4).Claim# (b)(4).
Additional Manufacturer Narrative
Correction data.B5 - reported as: reporter indicated that following the implant of a vicm5 13.2 -7.0 implantable collamer lens into the patient's right eye (od) on (b)(6) 2024.Concomitant products used intraoperatively include opegan and the msi injector delivery system.Toxic anterior segment syndrome (tass) was diagnosed.Bacteriological examination was performed and culture identification was negative.A treatment of anterior chamber cleaning + lens extraction was performed.On (b)(6) 2024 the lens was exchanged with a same model, length, and different power.Problems resolved.The cause of the event was unknown.Reportedly, there was pigment adhesion to the lens, but this was corrected by replacing the lens.- correct to: reporter indicated that following the implant of a vicm5 12.6 -7.0 implantable collamer lens into the patient's right eye (od) on (b)(6) 2024.Concomitant products used intraoperatively include opegan and the msi injector delivery system.Toxic anterior segment syndrome (tass) was diagnosed.Bacteriological examination was performed and culture identification was negative.A treatment of anterior chamber cleaning + lens extraction was performed.On (b)(6) 2024 the lens was exchanged with a same model, length, and different power.Problems resolved.The cause of the event was unknown.Reportedly, there was pigment adhesion to the lens, but this was corrected by replacing the lens.Claim# (b)(4).
Additional Manufacturer Narrative
Correction data: b2 - reported as ; required interventio to prevent permanent impairment/damage - correct to; other serious or important medical events.D2 - reported as; qcb - correct to: mta.H6 - healt effect - impact cod (f) reported as 4629 - correct to: 4627.Claim# (b)(4).
Additional Manufacturer Narrative
B5 - a reporter indicated that following the implant of a vicm5 12.6 -7.0 implantable collamer lens into the patient's right eye (od) on (b)(6) 2024.Concomitant products used intraoperatively include opegan and the msi injector delivery system.Toxic anterior segment syndrome (tass) was diagnosed.Bacteriological examination was performed, and culture identification was negative.A treatment of anterior chamber cleaning + lens extraction was performed.On (b)(6) 2024 the lens was exchanged with a same model length and different power.It was reported that recovery was observed on day seven post-op.Problems resolved.The cause of the event was unknown.Reportedly, there was pigment adhesion to the lens, but this was corrected by replacing the lens.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: 20346727
• Report Number: 2023826-2024-04417
• Device Sequence Number: 8055233
• Product Code: QCB
• UDI-Device Identifier: 00840311311767
• UDI-Public: (01)00840311311767(11)230123(17)251231
• 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,Followup,Followup
• Report Date (Section B): 09/10/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 11/15/2024; 12/13/2024; 12/13/2024; 01/16/2025; 09/19/2025
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/19/2024; 01/07/2025; 01/07/2025; 02/18/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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.; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK.; INJECTOR MODEL#MSI-PF,LOT#UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male