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

Model Number VTICM5_13.7

Device Problem Optical Problem (3001)

Patient Problem Corneal Edema (1791)

Event Date 10/17/2023

Event Type  malfunction  

Manufacturer Narrative

A4 - unk.A5 - unk.A6 - unk.H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.7mm vticm5_13.7, -14.0/1.0/091 (sphere/cylinder/axis), implantable collamer lens into the patient's left eye (os) on (b)(6)2023.On (b)(6) 2023 corneal edema and cloudy vision was observed.Lens remains implanted.On (b)(6) 2023 patient healing well.Problem resolved.

Manufacturer Narrative

Date of event: 10-nov-2023 corrected to 17/oct/2023.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 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia 91016
• MDR Report Key: 18210935
• MDR Text Key: 329033006
• Report Number: 2023826-2023-05248
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542118743
• UDI-Public: 00841542118743
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

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
• Device Model Number: VTICM5_13.7
• 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: 11/06/2023
• Initial Date FDA Received: 11/27/2023
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2023
• 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: UNK.
• Patient Outcome(s): Congenital Anomaly
• Patient Sex: Male