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

Model Number	VTICMO13.7
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inflammation (1932)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Manufacturer narrative: intraocular 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.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.An inflammatory response is common after intraocular surgery; however, this is usually mild and does not require any additional interventions beyond the standard post-op regimen.In some cases, the degree of inflammation may be more severe.Surgical technique, inadvertent intraoperative trauma and the use of pro-inflammatory substances into the eye may have contributed to the event.Claim#: (b)(4).
Event or Problem Description
A facility representative reported that after implantable collamer lens (icl) implantation into the patient's eye, inflammation was observed in the anterior chamber.Date of onset and severity was not provided.Information regarding concomitant products used intraoperatively was not provided.Diagnostic cultures have not been reported, and no information regarding medical intervention has been provided.It was noted that 13 additional cases from the same surgeon within the same facility reported similar postoperative outcomes.The lens remains implanted within the patient's eye.No further information is available at this time.If additional information is received, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
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 that 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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker ave; monrovia, CA 91016
• MDR Report Key: 20007112
• Report Number: 2023826-2024-03738
• Device Sequence Number: 7123459
• Product Code: QCB
• UDI-Device Identifier: 00840311331406
• UDI-Public: 00840311331406
• 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,Company Representative
• 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
• Operator of Device: Health Professional
• Device Model Number: VTICMO13.7
• Device Catalogue Number: N/A
• 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: 07/22/2024
• Supplement Date Received by Manufacturer: 11/17/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2023
• 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