MAUDE Adverse Event Report: ALCON LENSX, INC. LENSX LASER SYSTEM; OPHTHALMIC FEMTOSECOND LASER

Model Number 550

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 11/05/2015

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.Additional information has been requested but not received to date.Software version 2.30b.(b)(4).

Event Description

A customer reported that the flap of the second eye of a patient was not cut in the correct level.The surgeon could not lift the patient's left eye flap.The surgery was cancelled.The patient's right eye had been operated before without any issue.Additional information was provided by a company representative who clarified that the flap patient interface was loosely locked with the bayonet fitting of the laser.Patient outcome was unknown.Additional information has been requested but not received to date.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Evaluation summary: the creation of a corneal flap is used in patients undergoing lasik surgery or other treatment requiring initial lamellar resection of the cornea.Anatomical abnormalities or patient movement should be addressed prior to the use of the laser, as this may cause an issue with the flap creation.Contraindications include: patients¿ with previous health/eye history, pediatric patients, or patients with corneal abnormalities which would prevent the wavelength (laser beam) from transmitting.A flap resection consists of two resections.The first is a circular lamellar disc cut, parallel to the anterior surface.A second resection is a partial cylindrical wall that extends from the lamellar disc to the anterior surface.A portion of the second resection is left untreated to create a hinge.Flap parameters must be specified or verified prior to initiating the laser surgical procedure.All positioning and pattern adjustment occurs in the planning and docking steps.As with any surgical procedure, risk is involved.Possible complications resulting from lamellar flap resection include (but are not limited to): corneal edema, corneal pain, epithelial in-growth, epithelial defect, infection, flap de-centration, incomplete flap creation, flap tearing or incomplete lift-off.The system was examined by a company representative.The company representative noted the bayonet ring of the objective was loose; which could cause the patient interface (pi) to fit loosely on the objective.The ring was tightened to address the issue.The laser met specifications at the time of release.There are multiple factors that may contribute or cause this issue; including non-system factors (e.G.Patient anatomy and patient movement).Thus, based on the information obtained, the root cause of this event could not be determined conclusively.Based on the investigation results, the root cause of the reported event could not be determined.

• Brand Name: LENSX LASER SYSTEM
• Type of Device: OPHTHALMIC FEMTOSECOND LASER
• Manufacturer (Section D): ALCON LENSX, INC.; 33 journey; suite #175; aliso viejo CA 92658
• Manufacturer (Section G): ALCON LENSX, INC.; 33 journey; suite #175; aliso viejo CA 92658
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5252784
• MDR Text Key: 32362661
• Report Number: 3008772169-2015-00834
• Device Sequence Number: 1
• Product Code: OOE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 550
• Device Catalogue Number: 8065998162
• Other Device ID Number: 00380659981623
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR