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 Date 03/15/2024

Event Type  Injury  

Event Description

The surgeon implanted a vicm5 13.2 -07.00d implantable collamer lens into the patient's right eye (od) on (b)(6) 2024.Concomitant products used intraoperatively include opegan and the msi injector delivery system.Toxic anterior segment syndrome ( tass) was observed and per reporter, unknown diagnostics and treatment were performed.On (b)(6) 2024 (day 8) the lens was exchanged.Anterior chamber irrigation and evacuation of visco/fluids was performed.The lens was exchanged with another icl of the same model, length, and power.Problems resolved.The last report was received on 02-apr-2024.In the reporter's opinion, the cause of the event was unknown.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

A4: unk.A5: unk.A6: unk.H6 - work order search: another similar complaint was reported for units within the same lot.H11: manufacturer narrative: a review of the device labeling was completed.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.Given the information that additional procedure for visco/fluids was performed it is very likely that the event was not device related in origin.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.To date both the crystalline lens and the icl remain implanted.Claim # (b)(4).

Manufacturer Narrative

H6: 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)
• 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: 19195772
• MDR Text Key: 341238387
• Report Number: 2023826-2024-01672
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00840311300877
• UDI-Public: 00840311300877
• 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: 04/01/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/04/2023
• 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
• Treatment: CARTRIDGE MODEL SFC-45 - LOT # UNK; FOAM TIP PLUNGER MODEL FTP - LOT # UNK; INJECTOR MODEL MSI-PF - LOT # UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Sex: Male