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

Model Number	VICM5_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	03/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: device evaluation: particles were identified on the returned lens.The lens was sent out to an external lab for analysis.The review of the manufacturing process found no materials with a similar composition.Claim # (b)(4).
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.Claim # (b)(4).
Event or Problem Description
The surgeon implanted a vicm5 13.2 -07.00d 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 observed and per reporter, unknown diagnostics and treatment were performed.On (b)(6) 2024 (day 8) the lens was exchanged.Anterior chamber irrigation and evacuation of visco/fluids was performed.The lens was exchanged with another icl of the same model, length, and power.Problems resolved.The last report was received on 02-apr-2024.In the reporter's opinion, the cause of the event was unknown.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
A4: unk.A5: unk.A6: unk.H6 - work order search: another similar complaint was reported for units within the same lot.H11: manufacturer narrative: a review of the device labeling was completed.The dfu provides the surgeon instruction for complete ovd removal.Precaution: (6) after inserting this product, aspirate the viscoelastic substance completely from inside the eye.Do not use highly viscous viscoelastic substances that are difficult to aspirate completely.Given the information that additional procedure for visco/fluids was performed it is very likely that the event was not device related in origin.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.To date both the crystalline lens and the icl remain implanted.Claim # (b)(4).
Additional Manufacturer Narrative
B5 - the surgeon implanted a vicm5 13.2 -07.000 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 observed and per reporter, unknown diagnostics and treatment were performed.The lens exchange occurred approximately one-week post implantation and inflammatory recovery was observed at 41 days post-operatively.Anterior chamber irrigation and evacuation of visco/fluids was performed.The lens was exchanged with another icl of the same model, length, and power.Problems resolved.The last report was received on 02-apr-2024.In the reporter's opinion, the cause of the event was unknown.Additional information has been requested but none has been forthcoming.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 ; 6263037902
• MDR Report Key: 19195772
• Report Number: 2023826-2024-01672
• Device Sequence Number: 15363854
• Product Code: MTA
• UDI-Device Identifier: 00840311300877
• UDI-Public: 00840311300877
• 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
• Report Date (Section B): 04/01/2024

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: 08/31/2026
• Device Model Number: VICM5_13.2
• 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: 04/01/2024
• Supplement Date Received by Manufacturer: 05/10/2024; 05/10/2024; 09/12/2025
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 05/29/2024; 06/24/2024; 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2023
• 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 MODEL FTP - LOT # UNK; INJECTOR MODEL MSI-PF - LOT # UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 26 YR
• Patient Sex: Male