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

Model Number	VTICM5 12.1 (-8.00/ 1.0)
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endophthalmitis (1835); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6- health effect- clinical code: 4581- ' pigment dispersion'.H6- investigation type code: 4110- lens work order search- no similar complaint event(s) within associated lots were found.H11.- endophthalmitis is a rare vision-threatening intraocular inflammation, most commonly due to exogeneous organisms introduced via ocular surgery, intravitreal injections, or trauma.See dfu warning: staar surgical icls are packaged and sterilized for single use only.Cleaning, refurbishment and/or resterilization does not apply to these instruments.If one of these instruments is reused after cleaning, refurbishment and/or resterilization, there is a high probability that the instrument has become contaminated, which may lead to endophthalmitis and inflammation.Given the onset of reported problem without results of cultures provided, an exact cause could not be determined as the lens remains implanted.The event could be multifactorial in nature including patient and/or procedure related factors.Claim# (b)(4).
Event or Problem Description
A facility representative reported that following an implantable collamer lens (icl) implantation procedure on (b)(6) 2025, into the patient's left eye (os) the patient experienced endophthalmitis, pigment dispersion and medication was prescribed.Reportedly, "asepetic inflammation with pigment cell deposition".The patient underwent bilateral sequential surgery.Diagnostics and treatment was performed but the results of these were not provided.The lens remains implanted.Per last visit on (b)(6) 2025, bcva was recorded as 20/20 (pre-op bcva not provided) with a vault of 374 m and an iop of 16 mmhg.The cause of the event was reported as unknown.There are multiple medical device reports associated with this patient.This report is 2 of 2 total reports.Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.This report is part of a bolus submission of individually reported events identified during a retrospective review by the customer covering a six-month period.Each case is submitted separately and does not indicate a temporal cluster.This timeline also highlights a delayed onset of the bolus reported events relative to the procedure date (average: 26 days, range:17-35 days, as well as a delay in reporting due to retrospective case identification.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
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.Corrected data: b5.- a facility representative reported that following an implantable collamer lens (icl) implantation procedure on (b)(6) 2025, into the patient's left eye (os) the patient experienced endophthalmitis, pigment dispersion and medication was prescribed.Reportedly, "asepetic inflammation with pigment cell deposition".The patient underwent bilateral sequential surgery.Diagnostics was not performed.Treatment was performed but the results of these were not provided.The lens remains implanted.Per last visit on (b)(6) 2025, bcva was recorded as 20/20 (pre-op bcva not provided) with a vault of 374 m and an iop of 16 mmhg.The cause of the event was reported as unknown.There are multiple medical device reports associated with this patient.This report is 2 of 2 total reports.Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.This report is part of a bolus submission of individually reported events identified during a retrospective review by the customer covering a six-month period.Each case is submitted separately and does not indicate a temporal cluster.This timeline also highlights a delayed onset of the bolus reported events relative to the procedure date (average: 26 days, range:17-35 days, as well as a delay in reporting due to retrospective case identification.If additional information is received a supplemental medwatch report will be submitted.Claim# (b)(4).

• Brand Name: EVO/EVO+ VISIAN IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC TORIC 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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 22879554
• Report Number: 2023826-2025-01222
• Device Sequence Number: 5688256
• Product Code: QCB
• UDI-Device Identifier: 00840311304424
• UDI-Public: (01)00840311304424(11)240228(17)270131
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2025

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 Model Number: VTICM5 12.1 (-8.00/ 1.0)
• Device Catalogue Number: VTICM5 12.1
• 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: 07/28/2025
• Supplement Date Received by Manufacturer: 08/31/2025
• Initial Report FDA Received Date: 08/22/2025
• Supplement Report FDA Received Date: 09/09/2025
• Date Device Manufactured: 02/28/2024
• 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# 1777810.; FOAM TIP PLUNGER (FTP), LOT# 1756753.; INJECTOR MODEL: MSI-PF, LOT# 1820741.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR
• Patient Sex: Female