MAUDE Adverse Event Report: INTREPID BIMANUAL POLYMER DISPOSABLE I/A SET; DEVICE, IRRIGATION, OCULAR SURGERY

Catalog Number	8065751922
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Edema (1791); Hypopyon (1913); Uveitis (2122); Vitritis (2181); Fibrosis (3167); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	05/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No sample has been received at manufacturing for evaluation.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.This is the fourth of seven reports for this reported patient event.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A surgeon reported a patient experienced toxic anterior segment syndrome (tass) following a cataract extraction procedure.The patient presented post-operative day one with inflammation, hypopyon and corneal edema.Upon examination of the patient, the surgeon noted 4+ aqueous cell, and 3+ vitreous inflammation.The patient was treated with additional steroid eye drops.No cultures were performed.The patient's symptoms have resolved.This report represents the three of three patients for this surgeon.
Additional Manufacturer Narrative
Fda patient event code "3167" was incorrectly selected and has been removed.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information is provided in sections h.6 and h.10.A sample was not received at the manufacturing site for evaluation; therefore, the condition of the product could not be verified.A review of the device history record (dhr) traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A review of the sterilization records indicates that the product was sterilized and released according to the product's acceptance criteria.Because a sample was not received and the dhr review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, the root cause for customer complaint issue cannot be determined.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.All handpieces are 100% visually inspected prior to being released from the manufacturing facility.Data will continue to be monitored for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: INTREPID BIMANUAL POLYMER DISPOSABLE I/A SET
• Common Device Name: DEVICE, IRRIGATION, OCULAR SURGERY
• MDR Report Key: 12085673
• Report Number: 2523835-2021-00229
• Device Sequence Number: 17111343
• Product Code: KYG
• UDI-Device Identifier: 00380657519224
• UDI-Public: 00380657519224
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 8065751922
• Device Lot Number: 13RRLH
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 08/04/2021; 09/17/2021
• Initial Report FDA Received Date: 06/29/2021
• Supplement Report FDA Received Date: 08/20/2021; 10/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALANCED SALT SOLUTION 15ML; BALANCED SALT SOLUTION 500ML; POVIDONE IODINE; TETRACAINE; BALANCED SALT SOLUTION 15ML; BALANCED SALT SOLUTION 500ML; POVIDONE IODINE; TETRACAINE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR