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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Event Description

At an (b)(6) surgeon user meeting, a surgeon reported a patient that was implanted with an icl implantable collamer in 2019 that developed either tass or post-op inflammation.The patient recovered and there were no issues.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

A2: unk.A3: unk.A4: unk.A5: unk.A6: unk.B3: unk.D4: expiration date unk.D6a: unk d6b: unk h4: unk h11: additional manufacturer narrative: a review of the device labeling was completed.Iritis and intraocular infection are identified in the labeling as a known adverse event following icl implantation.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 inhale should not be used.A dfu states a caution: 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.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.Claim # 733938.

Manufacturer Narrative

Corrected data: b1: product problem h1: malfunction h6: medical device problem code (a): 3189.Claim #(b)(4).

• 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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18852797
• MDR Text Key: 337068720
• Report Number: 2023826-2024-00851
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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?: Yes
• 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: Not provided
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention