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

Model Number	VTICMO 13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endophthalmitis (1835); Inflammation (1932)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported that following a toric implantable collamer lens (icl) implantation procedure on (b)(6) 2024, into the patients left eye (os), the patient presented with "suspected endophthalmitis" 18 days after implantation.The patient underwent bilateral sequential surgery.Diagnostic culture was not performed.The patient was prescribed treatment with frequent steroid drops.Per last visit on (b)(6) 2024 the issue is reported as resolved with the reported visual acuity to be: bcva & ucva 20/20.The lens remains implanted.The cause of the event was reported as unknown.
Additional Manufacturer Narrative
H6- investigation type code: 4110- lens work order search- no similar complaint event(s) within associated lots were found.H11- manufactuer narrative: a review of the device labeling was completed.Intraocular infection is identified in the labeling as a known potential adverse event following icl implantation.The dfu states a precaution (3): the lens must not be exposed to any solution other than normally used intraocular perfusion fluids (e.G., isotonic saline, bss, viscoelastic solutions, etc.).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 and resolution without cultures taken, an exact cause could not be determined as the event resolved and lens remains implanted.The event could be multifactorial in nature including patient and/or procedure related factors.(b)(4).
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.(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 ; 6263037902
• MDR Report Key: 20147856
• Report Number: 2023826-2024-03900
• Device Sequence Number: 4275579
• Product Code: QCB
• UDI-Device Identifier: 00840311328529
• UDI-Public: 00840311328529
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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: 10/31/2022
• Device Model Number: VTICMO 13.2
• 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: 08/14/2024
• Supplement Date Received by Manufacturer: 11/17/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 11/20/2024
• Date Device Manufactured: 11/14/2023
• 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 (FTP), LOT# UNK.; MSI-PF, LOT# UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male