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

Model Number	VICM512.6
Medical Device Problem Codes	Misfocusing (1401); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	06/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: work order search: no similar complaints within associated lots were found.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm vicm512.6 implantable collamer lens of -7.0 diopter was implanted into the patient's left eye (os) on (b)(6) 2023.Toxic anterior segment syndrome (tass) was observed.Diagnostics were performed.Anterior chamber lavage subconjunctival steroid injection, oral medicine, and ophthalmic drops.Decadron subconjunctival injection, prednisone 10mg, every hour (vegamox, tobracin, rinderon.The problem was resolved.Reportedly, "tass is occuring on a regular basis." cause of the event was the device.
Additional Manufacturer Narrative
Corrected data: b5- the reporter indicated the surgeon implanted a 12.6mm vicm5_12.6 implantable collamer lens of diopter -7.00 into the left eye (os) on (b)(6) 2023.The patient experienced toxic anterior segment syndrome (tass).Treatment and diagnostics were performed.Anterior chamber lavage was performed and subconjunctival steroid injection, oral steroids and topical drops (antibiotics and steroids) were prescribed.The lens remains implanted and the problem was resolved.The cause of the event was the device.Cause details provided: "tass is occurring on a regular basis." h6-health effect- impact code: "4625" and "4614" should be added.H6- medical device code: "1401" should be removed and "2993" should be added.Additional data: h6- type of investigation code: 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 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 ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17322213
• Report Number: 2023826-2023-02770
• Device Sequence Number: 6365512
• Product Code: MTA
• UDI-Device Identifier: 00840311300549
• UDI-Public: 00840311300549
• 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
• Report Date (Section B): 06/27/2023

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: 01/31/2026
• Device Model Number: VICM512.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2023
• 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 Sex: Female