MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE CLEARCUT INTREPID KNIVES; KNIFE, OPHTHALMIC

Catalog Number 8065992445

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/26/2018

Event Type  malfunction  

Manufacturer Narrative

No sample has been received by 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.Additional information has been requested.(b)(4).

Event Description

An operating room technician reported that a knife was used during cataract surgery when a fleck of metal was noted inside of the patient's eye.The surgery was completed, but the metal fleck could not be irrigated out of the eye.Additional information received indicates that the fleck is lodged in the iris of the patient's right eye.No additional information is anticipated for this report.

• Brand Name: CLEARCUT INTREPID KNIVES
• Type of Device: KNIFE, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7764937
• MDR Text Key: 116867281
• Report Number: 2523835-2018-00369
• Device Sequence Number: 1
• Product Code: HNN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 8065992445
• Device Lot Number: 248879M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2018
• 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): Other