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

Model Number VICM5 13.2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Toxic Anterior Segment Syndrome (TASS) (4469)

Event Type  Injury  

Manufacturer Narrative

H6-investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.A review of the device labeling was completed.The directions for use identifies that foreign matter adhering to the lens surface may occur with the insertion of a phakic posterior chamber lens.In that case, it is necessary to stop inserting the lens, or to remove the lens.Inserter damage, deformation, lens clogging and poor lens behavior were also identified.The dfu provides the surgeon instruction for complete ovd removal.Precaution: (6) after inserting this product, aspirate the viscoelastic substance completely from inside the eye.Do not use highly viscous viscoelastic substances that are difficult to aspirate completely.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.To date both the crystalline lens and the icl remain implanted.Claim#: (b)(4).

Event Description

The reporter indicated that a 13.2mm vicm5 -8.00d implantable collamer lens was implanted by the surgeon into the patient's eye on an unknown date.Concomitant ovd and delivery system information was not provided.Day 1 onset of toxic anterior segment syndrome (tass) was noted.Diagnostic cultures were not performed.Antibiotic and steroid ophthalmic drops were prescribed.The cause of the event was thought to be contamination or residue in the lens vial or injector.Subjective symptoms improved with the last visual acuity noted as of (b)(6) 2024 to be 1.0 (20/20).The reporter notes crystalline lens clouding.The lens remains implanted.

Manufacturer Narrative

Device history record (dhr) review: based on the results of the investigation, all released devices from the associated work orders(s), including the suspected device, have been manufactured within established parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.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
• MDR Report Key: 19075268
• MDR Text Key: 339774612
• Report Number: 2023826-2024-01568
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00840311300891
• UDI-Public: 00840311300891
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/15/2024

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
• Device Operator: Health Professional
• Device Model Number: VICM5 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 05/21/2024
• Date Device Manufactured: 04/12/2023
• 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