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

Model Number	VICM512.1
Medical Device Problem Code	Misfocusing (1401)
Health Effect - Clinical Code	Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	07/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4-a6:unk.H6: work order search: no similar complaints within associated lots were found.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 12.1mm vicm512.1 implantable collamer lens of -8.5 diopter was implanted into the patient's left eye (os) on (b)(6) 2023.Toxic anterior segment syndrome (tass) was observed.Diagnostics was performed: iop, visual acuity, and casia.Rinderon was used for treatment.The problem was resolved.Status of the eye is stated, "anterior chamber abscess 3 weeks after surgery (1 aug) recovered (felt a little kp remaing on the lens) on 21 aug." cause of the event was the device with the lens not performing as intended.Reportedly, "found foreign objects on the lens when inserting".
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.H10 - prior supplemental mdr #1 should be n/a as it was submitted in error - was intended for another complaint.Claim#: (b)(4).
Additional Manufacturer Narrative
Additional data: h3 - device evaluation: the lens was returned in liquid in a microcentrifuge vial with residue and debris on the lens.Visual inspection found the haptic broken and with fibre on the lens.Dimensional and functional inspection found the lens to be within specifications.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 ; 800 royal oaks dr. suite210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17786414
• Report Number: 2023826-2023-04091
• Device Sequence Number: 7491288
• Product Code: MTA
• UDI-Device Identifier: 00840311300242
• UDI-Public: 00840311300242
• 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: 2023
• 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
• Report Date (Section B): 09/03/2023

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: 12/31/2025
• Device Model Number: VICM512.1
• 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: 09/03/2023
• Supplement Date Received by Manufacturer: 11/27/2023; 12/21/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 12/15/2023; 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2023
• 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; FOAM TIP PLUNGER - LOT# UNK; INJECTOR MODEL: MSI-PF - LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Male