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

Catalog Number 8065992745

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2016

Event Type  malfunction  

Manufacturer Narrative

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.(b)(4).

Event Description

A customer reported they had a bad batch of blades during surgery.The surgeon stated he needed to put in a suture.There was no patient harm.Additional information has been requested but none has been received.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

No sample has been returned for evaluation for the report of dull blades; therefore, the condition of the product could not be verified.A review of the related device history records for the reported lot number, indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there are no other complaints associated with the lot for the reported issue.A sample was not returned and the device history record 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.(b)(4).

• Brand Name: CLEARCUT 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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5710022
• MDR Text Key: 48130491
• Report Number: 2523835-2016-00476
• 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: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 8065992745
• Device Lot Number: 140584M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• 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