MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HOUSTON SMALL PART KIT; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065751526

Device Problem Insufficient Information (3190)

Patient Problem Tissue Damage (2104)

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 pharmacist reported experiencing several problems with the sleeve which wounds the descemet membrane.The number of patients involved is unknown.Additional information has been requested.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

As the customer did not retain the finished goods lot number, device history record and lot history could not be reviewed.The customer did not retain a sample for this complaint report; visual inspection or functional testing could not be conducted.The root cause of the customer's complaint could not be established as a sample has not been received.Without a sample, it is not possible to isolate the root cause.After a thorough investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information has been requested and received.The descemet detachment occurred at the end of the phacoemulsification.The detachment reassembled naturally.The surgeon considers that it was caused by the passage of the sleeve in the incision.During the introduction and return movement, it did not appear right away at the first introduction of the handpiece, but it was present at the end.The surgeon reported modification of the incision and changing of the knife with no results.

• Brand Name: SMALL PART KIT
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6803354
• MDR Text Key: 83198860
• Report Number: 1644019-2017-00697
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751526
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2017
• Initial Date FDA Received: 08/18/2017
• Supplement Dates Manufacturer Received: 08/31/2017; 09/22/2017; 11/01/2017
• Supplement Dates FDA Received: 09/06/2017; 10/12/2017; 11/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other