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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6-investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.Inflammation is identified in the labeling as a known potential adverse event following icl implantation.The icl directions for use (dfu) states under adverse events: as with implantation of other types of intraocular lenses, potential adverse events can include, but are not limited to infection and iritis.The dfu states precautions to physicians (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.).The dfu states a warning: complete removal of viscoelastic from the eye after completion of the surgical procedure is essential.Viscoelastic instruments that may be difficult to aspirate should not be used.The dfu states for preparation: verify that the vial is filled at least 2/3 full with liquid.Thermoshaping trays and vials must be opened in a sterile site.Record the control number on the operative report to maintain traceability.Remove aluminum cap and stopper.Using the foam plunger tip, remove the crystals from the vial.Crystals should not be exposed to dry conditions (air) for more than one minute.Warning: do not allow the crystals to dry out after removing them from the glass bottle.Additional warning: staar surgical icl and disposable accessories are packaged and sterilized for single use only.Cleaning, refurbishing and/or resterilization are not applicable to these devices.If one of these devices were reused after cleaning or refurbishing, it is highly probable that it would be contaminated, and the contamination could result in infection and/or inflammation.Warning: the intraocular lens should not be implanted if the sterile packaging has been opened or damaged.While improper sterilization and contamination of surgical instruments remains the most common risk factor associated with severe post-op inflammation, ocular viscoelastic, and improper preparation of antibiotics for intracameral injection may also be a contributing factor.Given the onset of reported problem was bilateral, without cultures taken, 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 two weeks after bilateral implantable collamer lens (icl) implantation into the patient's eye, inflammation observed bilaterally on po week 2.Information regarding concomitant products used intraoperatively was not provided."deposits" (unspecified) were noted on the icl.No further description of the deposits was provided, and diagnostic cultures have not been reported.It was reported that the patient experienced no other reaction and the lens remains implanted.No further information is available at this time.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
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.Corrected data.D4: primary unique device identifier (udi) #: (b)(4)."udi related data quality updates only." 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: 20027652
• Report Number: 2023826-2024-03569
• Device Sequence Number: 7364176
• Product Code: QCB
• UDI-Device Identifier: 00840311327447
• UDI-Public: (01)00840311327447(11)231024(17)260930(21)T1737191
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 07/22/2024

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
• Device Expiration Date: 09/30/2026
• 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: 07/22/2024
• Supplement Date Received by Manufacturer: 11/17/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 11/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2023
• 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