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

Model Number	VICM5 13.2(-4.0)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Toxic Anterior Segment Syndrome (TASS) (4469)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1 - unk.A2 - unk.A3 - unk.A4 - unk.A5 - unk.A6 - unk.D6a - unk.H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 13.2mm, vicm5_13.2, -4.0 diopter, implantable collamer lens was implanted into the patient's right eye (od).Toxic anterior segment syndrome (tass) was observed eight days after surgery.Eye drops and steroid prescribed.Improved visual acuity (0.9 to 1.5).Lens remains implanted.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
H6 - type of investigation 3331 - 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 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.Claim # (b)(4).
Event or Problem Description
B5 - the reporter indicated that following an implantable collamer lens (icl) implantation procedure, the patient experienced toxic anterior segment syndrome (tass).The lens remains implanted.Concomitant products used during surgery, including ovd information, were not provided.The onset of symptoms was 8days after surgery.No conformity diagnostic tests were reported.Medical management with antibiotics and steroids was described as betamethasone valerate, gentamicin sulfate frequent eyes drops, and dexamethasone oral.The improved visual acuity (0.9-->1.5) and with anterior chamber empyema (hypopyon).As per the updated claim file, it was reported that inflammatory recovery was observed 200 days after surgery.Claim #(b)(4).
Additional Manufacturer Narrative
B5 - the reporter indicated that following an implantable collamer lens (icl) implantation procedure, the patient experienced toxic anterior segment syndrome (tass).The lens remains implanted.Concomitant products used during surgery, including ovd information, were not provided.The onset of symptoms was 8days after surgery.No conformity diagnostic tests were reported.Medical management with antibiotics and steroids was described as betamethasone valerate, gentamicin sulfate frequent eyes drops, and dexamethasone oral.The improved visual acuity (0.9-->1.5) and with anterior chamber empyema (hypopyon).As per the updated claim file, it was reported that inflammatory recovery was observed 200 days after surgery.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: 19021323
• Report Number: 2023826-2024-01378
• Device Sequence Number: 3809382
• Product Code: MTA
• UDI-Device Identifier: 00840311300815
• UDI-Public: (01)00840311300815(11)230515(17)260430(21)S1956929
• 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): 03/15/2024

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: 04/30/2026
• Device Model Number: VICM5 13.2(-4.0)
• Device Catalogue Number: VICM5 13.2
• Device Lot Number: N/A
• 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: 03/15/2024
• Supplement Date Received by Manufacturer: 06/26/2024; 03/04/2026
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 06/27/2024; 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown