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

Model Number	VTICM5_12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Endophthalmitis (1835)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - type of investigation - lens work order search: no similar complaint type events reported for units within the same lot.Manufacturer narrative: a review of the device labeling was completed.Endophthalmitis is identified in the labeling as a potential adverse event following icl implantation.Per the directions for use complications and adverse reactions implantation of any evo|evo+ icl may include but are not limited to: intraocular infection and secondary surgical intervention to remove/replace the lens.The dfu states a caution: staar surgical evo|evo+ ticl and disposable accessories are packaged and sterilized for single use only.Cleaning, reuse and/or resterilization are not applicable to these devices.If one of these devices were reused after cleaning and/or resterilization, it is highly probable that it would be contaminated, and the contamination could result in infection and/or inflammation.An exact cause could not be determined as the event could be multifactorial in nature including patient and/or procedure related factors.The lens was explanted and returned.Claim# (b)(4).
Event or Problem Description
The reporter indicated that a 12.6mm vticm5 implantable collamer lens of -10.50/+1.50/100 power was implanted into the patients left eye (os) on (b)(6) 2024.Postop ciproxacino and maxidex drops were given.On (b)(6) 2024 the lens was explanted due to observation of endophthalmitis.Anterior chamber wash and intravitreal corticosteroid/antibiotic treatment occurred.Oral antibiotics were also given.Diagnostic cultures were performed with lab results negative for organisms.There is no report of loss of visual acuity.On (b)(6) 2024 it was reported the patient has a suture in place and was doing well.The patient will undergo icl reimplantation two months later.
Additional Manufacturer Narrative
B5: per updated information the patient was seen, the stitches were removed and visual acuity is 20/20 with correction.The endophthalmitis was reported to be resolved.H6: inspection of the returned device identified four particulates on the lens.External laboratory analysis was performed to determine the size and composition of the particulates identified on the lens.First particle: found to be primarily composed of cellulosic material, second particle: primarily composed of protein and fat, third particle: primarily composed of amorphous carbon, with trace elements including oxygen, sodium, chlorine, nitrogen, aluminum, sulfur, and iron, fourth particle: primarily composed of stainless steel, with trace amounts of carbon, oxygen, silicon, sodium, chlorine, aluminum, and nitrogen.Unfortunately, we were unable to conclusively identify the source of the elements found in the sem-edx and ftir analyses.H6- device history record (dhr) review: based on the results of the investigation, the dhr review indicates that the product has been manufactured within the established process parameters and there is no indication that the manufacturing and/or processing of the device contributed to the complaint issue.Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC 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
• MDR Report Key: 18984029
• Report Number: 2023826-2024-01347
• Device Sequence Number: 15555001
• Product Code: QCB
• UDI-Device Identifier: 00840311308118
• UDI-Public: 00840311308118
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2024

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 Model Number: VTICM5_12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 03/26/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• 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 W/FTP, LOT# UNK; INJECTOR MODEL: MSI-PF, LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female