MAUDE Adverse Event Report: STAAR SURGICAL COMPANY EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS; PHAKIC INTRAOCULAR LENS

Model Number	VICM5 12.6 (-06.00)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endophthalmitis (1835); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device labeling was completed.Conjunctivitis and endophthalmitis are identified in the labeling as potential adverse events from icl implantation.Per the dfu some adverse events may require secondary surgery.The dfu under important basic notes states: (4) prior to surgery, thoroughly explain the expected effects, adverse events, future risks, etc.Associated with the use of this product to the patient who will be inserted with this product.An inflammatory response is common after intraocular surgery.In some cases, bilateral and prolonged or persistent inflammation suggests secondary systemic health or ocular issues or issues with the post-op medication regimen.Patient related factors is the reported cause of the inflammation (endophthalmitis); therefore, the event is not device related in origin.To date, there is no confirmation of identified microorganisms.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm vicm5 -6.00d implantable collamer lens was implanted into the patient's left eye (od) on (b)(6) 2024.The patient underwent bilateral implantation of icls.Concomitant products used during surgery were: opegan as viscoelastic and the staar injector system (msi-pf injector; sfc-45 with foam tip plunger).Reportedly approximately one month upon icl implantation the patient presented with "endophthalmitis" ou.Diagnostics were performed and described as "hyperemia" and nonspecific posterior ocular "discomfort" ou.Subsequent lens explant (od) occurred on (b)(6) 2024 one month after presentation of symptoms.Post-explant bcva 20/13 (same as pre-op) was noted at the last visit with pending re-implantation when symptoms improve.The reporter stated the cause of inflammation was attributed to patient related factors with no device failure.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
Additional information: h6- method code 3331: device history record (dhr) review: based on the results of the investigation, all released devices from the associated work orders(s), including the suspected device, have been manufactured within established parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.H6-investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.Corrected data: b5:the reporter indicated that a 12.6mm vicm5 -6.00d implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2024.The patient underwent bilateral implantation of icls.Concomitant products used during surgery were: opegan as viscoelastic and the staar injector system (msi-pf injector; sfc-45 with foam tip plunger).Reportedly approximately one month upon icl implantation the patient presented with "endophthalmitis" ou.Diagnostics were performed and described as "hyperemia" and nonspecific posterior ocular "discomfort" ou.Subsequent lens explant (od) occurred on (b)(6) 2024 one month after presentation of symptoms.Post-explant bcva 20/13 (same as pre-op) was noted at the last visit with pending reimplantation when symptoms improve.The reporter stated the cause of inflammation was attributed to patient related factors with no device failure.Additional information has been requested but none has been forthcoming.D4: primary unique device identifier (udi) #: (b)(4), "udi related data quality updates only." claim# (b)(4).
Additional Manufacturer Narrative
Additional information: b5-a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced toxic anterior segment syndrome (tass).Cultures test was not performed.This was a bilateral sequential surgery.In a separate visit the lens was explanted and the problem was resolved.Cause is reported as unknown.H6- clinical code: 4469.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: b5-a facility representative reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced discomfort.In a separate visit the lens was explanted and the problem was resolved.H6-clinical code- 4581 patient discomfort.H6-investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.H6- method code 3331: device history record (dhr) review: based on the results of the investigation, all released devices from the associated work orders(s), including the suspected device, have been manufactured within established parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Claim# (b)(4).

• Brand Name: EVO/EVO+VISIAN IMPLANTABLE COLLAMER LENS
• 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: 19552366
• Report Number: 2023826-2024-02650
• Device Sequence Number: 17327071
• Product Code: MTA
• UDI-Device Identifier: 00840311300525
• UDI-Public: (01)00840311300525(11)230923(17)260831(21)S2156829
• 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): 05/20/2024

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 12.6 (-06.00)
• Device Catalogue Number: VICM5 12.6
• 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: 05/20/2024
• Supplement Date Received by Manufacturer: 09/24/2024; 03/18/2025; 04/08/2026
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 09/25/2024; 04/07/2025; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2023
• 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# 1660117.; FOAM TIP PLUNGER (FTP), LOT# 1664338.; INJECTOR MODEL: MSI-PF, LOT# UNK.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Sex: Male