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

Device Problem No Apparent Adverse Event (3189)

Patient Problems Inflammation (1932); Toxic Anterior Segment Syndrome (TASS) (4469)

Event Type  malfunction  

Manufacturer Narrative

A4-a6:unk.B3: unk.D4 (experiation date); unk no serial number reported.D6a: unk.H4 (device manufacturing date): no serial number reported.Manufacturer's narrative: a review of the device labeling was completed.Iritis is identified in the labeling as a known adverse event from icl implantation.The dfu states potential adverse events can include iritis and may require secondary surgery.The dfu states, administration and instruction for use: complete removal of the viscoelastic material from the eye must be performed after completion of the surgical procedure and before the eye is closed (without sutures).A dfu caution states: staar surgical evo|evo+ icl and disposable accessories are packaged and sterilized for single use only.Cleaning, reuse and/or resterilization are not applicable to these devices.If one of these devices were reused after cleaning and/or resterilization, it is highly probable that it would be contaminated and the contamination could result in infection and/or inflammation.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).

Event Description

The reporter recently indicated that an implantable collamer lens was implanted into an unknown eye of a patient in 2019.Post-op inflammation or toxic anterior segment syndrome was observed.It was reported the patient recovered.Information regarding the delivery system and ovd type were not provided by the reporter.

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC 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 ; 800 royal oaks dr. suite:210; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18837462
• MDR Text Key: 336898627
• Report Number: 2023826-2024-00637
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 03/05/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1