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

Model Number VTICH12.6

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

Patient Problems Corneal Decompensation (1790); Corneal Edema (1791); Toxic Anterior Segment Syndrome (TASS) (4469)

Event Date 11/25/2023

Event Type  Injury  

Manufacturer Narrative

G4: this product is manufactured in the u.S.But not marketed in the u.S.H6: health effect impact code: 4644 - topical corticosteroids, oral antibiotics.H6 - work order search: no similar complaint was reported for units within the same lot.Claim#: (b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.6mm vtich12.6 implantable collamer lens, +04.00/+4.0/085 (sphere/cylinder/axis) in the patients right eye (od) on (b)(6) 2023.Toxic anterior segment syndrome (tass) was observed.Diffuse corneal edema diagnosed within 1 -2 days.Treatment of topical corticosteroids and oral antibiotics were prescribed.There was a diagnosis of corneal decompensation.The cause of the event was unknown.The lens remained implanted.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

B5: post op, the patient is better.Avuc 0.7.His best pre-op va was 0.6.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 TORIC 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: 18337518
• MDR Text Key: 330659872
• Report Number: 2023826-2023-05553
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2023

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: VTICH12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/15/2023
• Supplement Dates Manufacturer Received: 12/20/2023; 02/13/2024
• Supplement Dates FDA Received: 01/19/2024; 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/11/2022
• 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: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR
• Patient Sex: Male