MAUDE Adverse Event Report: RXSIGHT, INC. RXSIGHT INSERTION DEVICE

Model Number 63000

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Wound Dehiscence (1154); Eye Injury (1845)

Event Date 12/21/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer reference #: (b)(4).

Event Description

The treating physician reported to rxsight that a cartridge split occurred for the rxsight insertion device, during the primary cataract surgery.The treating physician stated that the cartridge split led to a dehiscence of one of the prior radial keratotomy (rk) incisions, requiring placement of two sutures.Rxsight's first awareness of this event was on 12/21/2023.

• Brand Name: RXSIGHT INSERTION DEVICE
• Type of Device: RXSIGHT INSERTION DEVICE
• Manufacturer (Section D): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• Manufacturer (Section G): RXSIGHT, INC.; 100 columbia; aliso viejo CA 92656
• Manufacturer Contact: jim zhang ; 100 columbia; aliso viejo, CA 92656 ; 9492736163
• MDR Report Key: 18531820
• MDR Text Key: 333090002
• Report Number: 3012712027-2024-00005
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K231466
• 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
• Report Date: 01/17/2024

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: 63000
• Device Catalogue Number: 63000
• Device Lot Number: A02-0936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2023
• 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
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White