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

Model Number	VICM5_12.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Iritis (1940); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	02/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgeon implanted a 12.6mm vicm5 -8.00d implantable collamer lens, into the patient's right eye (od) on (b)(6) 2024.During lens implantation the icl was manually extracted with forceps and reloaded into a new injector followed by successful placement.The surgeon reports during implantation the icl made contact with the iris aggressively and possibly with the adjacent conjunctiva.On day 3 an above normal inflammation was noted with presentation of iritis and hypopyon along with report of tass.On (b)(6) 2024 an anterior chamber tap was performed with fluid sent for bacterial culture.On the same day intravitreal antibiotics of vancomycin and ceftazidime were given by the retinal specialist.The reporter did not provide identification of microorganisms.By (b)(6) 2024, the patient was noted as "recovered completely" with hypopyon resolved.Atropine was given for dilation and vision reportedly improved to 20/40+1.The lens remains implanted.The reporter states the cause of the event was unknown.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
A4: unk.A5: unk.A6: unk.D6b: na.Health effect impact code - additional medications: 4644 - vancomycin, ceftazidime.Work order search: no similar complaint was reported for units within the same lot.Manufacturer narrative: a review of the device labeling was completed.Iritis, hypopyon and infection are identified in the labeling as known potential adverse events following icl implantation.The evo/evo+ 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, hypopyon and iritis.The dfu states under surgical precautions: a learning curve and individual surgeon variability was seen in the clinical trial in terms of removals and reinsertions of the icl lens at the time of surgery.Procedural factors including surgical technique, inadvertent intra-operative trauma and the use of pro-inflammatory substances into the eye may have contributed to the event.Toxic anterior segment syndrome (tass) is an acute sterile postoperative inflammation that can occur after uncomplicated or complicated intraocular surgery.While improper sterilization and contamination of surgical instruments remains the most common risk factor associated with tass, ocular viscoelastic, and improper preparation of antibiotics for intracameral injection may also lead to tass.An exact cause could not be determined as the event could be multifactorial in nature including patient and/or procedure related factors.(b)(4).
Additional Manufacturer Narrative
Device history record (dhr) review: the dhr review indicated 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 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 avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18991248
• Report Number: 2023826-2024-01185
• Device Sequence Number: 14189680
• Product Code: MTA
• UDI-Device Identifier: 00841542119146
• UDI-Public: 00841542119146
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2024

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: 01/31/2025
• Device Model Number: VICM5_12.6
• 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: 03/02/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2023
• 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: Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male