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

Model Number	VICM5_ 13.2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The reporter indicated the surgeon implanted an implantable collamer lens into the patient's right eye (od).The patient has pre-existing hypothyroidism and undergoes bilateral icl implantation.Information about concomitant products used including ovd and delivery system were not provided.An immediate post op fibrinous reaction was observed after lens implantation in both eyes (ou).Right eye wash out was performed in which fibrin recurred 30 mins after.Both eyes (ou) were given subconjunctival steroids and hourly steroid drops for 48 hrs.After treatment the vision, iop and vault were reported as normal.In the reporter's opinion the patient's young age and a pro-inflammatory health history contributed to this event.The lens remains implanted.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
H6- health effect- clinical code: 4581-acute fibrinous reaction.Manufacturer narrative: a review of the device labeling was completed.Iritis and secondary surgical intervention are identified in the labeling as known potential adverse events following icl implantation.The dfu provides the surgeon instruction for lens implantation.The dfu states precaution (7) safety and effectiveness of the lens has not been established in patients with: unstable refractive error in either eye, keratoconus, history of clinical signs of iritis/uveitis, synechia, pigment dispersion syndrome, pseudoexfoliation, insulin-dependent diabetes or diabetic retinopathy, history of previous ocular surgery including refractive corneal surgery.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.A prolonged or persistent inflammation suggests secondary systemic health issues or ocular issues or issues with the post-op medication regimen.A longer course of post-op medications may be required in some instances.Patient related factor of a pre-existing systemic health issue was identified as the cause of this event and therefore not device related.Claim# (b)(4).
Additional Manufacturer Narrative
Additional data: b5- the lens remains implanted and the problem was resolved.The cause of the event was reported as a patient related factor and the device did not fail to perform as intended.Cause details provided: "i suspect it was due to patients innate florrid inflammatory reaction- bilateral within 30 minutes of surgery".Additional information provided: "fibrinous inflammation completely resolved by 48 hours on intensive topical steroid eye drops.Patient had steroid response, with elevated iop, managed with topical pressure lowering drops, now off drops at 6 weeks post op and iop normalised.No residual inflammation or complications.Given florrid immediate post operative fibrinous reaction, reported case, although i feel this reaction was unique to patient.Hypothyroid and young - autoimmune condition ie.More likely to develop inflammation post op.No change to standard surgical approach." h6- type of investigation code: 4110- lens work order search- one similar complaint event(s) within associated lots were found.H6: health impact code: "4625 - additional surgery: anterior chamber washout" and "4644" should be added.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC LNTRAOCULAR 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: 19493746
• Report Number: 2023826-2024-02364
• Device Sequence Number: 7107391
• Product Code: MTA
• UDI-Device Identifier: 00840311300921
• UDI-Public: (01)00840311300921(11)240120(17)261231
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2024

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: VICM5_ 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: 05/17/2024
• Supplement Date Received by Manufacturer: 07/06/2024
• Initial Report FDA Received Date: 06/08/2024
• Supplement Report FDA Received Date: 09/18/2024
• Date Device Manufactured: 01/20/2024
• 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# UNK; FOAM TIP PLUNGER (FTP), LOT# UNK; MSI-PF, LOT# UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female