MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE CLEARCUT S INCISIONAL INSTRUMENTS (WITH SHARPS INJURY PROTECTION); KNIFE, OPHTHALMIC

Catalog Number 8065771541

Device Problems Dull, Blunt (2407); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

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

A physician reported that multiple knife blades were dull and dimpled the cornea when making the incision during surgery.There was no patient impact experienced.Additional information has been requested.

• Brand Name: CLEARCUT S INCISIONAL INSTRUMENTS (WITH SHARPS INJURY PROTECTION)
• 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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7028595
• MDR Text Key: 92526569
• Report Number: 2523835-2017-00773
• Device Sequence Number: 1
• Product Code: HNN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 8065771541
• Device Lot Number: 206059M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2017
• 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