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

Model Number 550

Device Problems Material Fragmentation (1261); Malposition of Device (2616)

Patient Problem Rupture (2208)

Event Date 03/19/2015

Event Type  Injury  

Event Description

A surgeon reported that following laser-assisted capsulotomy and lens fragmentation, an anterior rent on the posterior capsule was noted, which caused the lens to drop down into the vitreous.The surgeon noted the rent during cataract extraction.A vitrectomy was performed and an anterior chamber intraocular lens (aciol) was implanted.Additional information provided by a company representative indicated that instead of using forceps to remove the capsulotomy, the surgeon used the phaco tip, after injecting the viscoelastic.The surgeon also reported that he usually presses the lens up and down to prevent capsular block, and to ensure the lens is free of the capsule.The surgeon did not specify in which step of the procedure the rent could have occurred.No additional information is expected.

Manufacturer Narrative

Evaluation summary: 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).

Manufacturer Narrative

Evaluation summary: no sample is expected for evaluation.The device history records (dhr) for the device was reviewed.No abnormalities that could have contributed to this event were found.The associated device was released based on the manufacturer's acceptance criteria.The root cause could not be determined conclusively.(b)(4).

• Brand Name: LENSX LASER SYSTEM
• Type of Device: OPHTHALMIC FEMTOSECOND LASER
• Manufacturer (Section D): ALCON LENSX LASERS, INC.; 33 journey; suite #175; aliso viejo CA 92658
• Manufacturer (Section G): ALCON LENSX LASERS, INC.; 33 journey; suite #175; aliso viejo CA 92658
• Manufacturer Contact: janet moran ; 6201 south freeway; mail stop r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4680968
• MDR Text Key: 5622144
• Report Number: 3008772169-2015-00539
• Device Sequence Number: 1
• Product Code: OOE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 550
• Device Catalogue Number: 8065998162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/26/2015
• Date Device Manufactured: 09/30/2013
• 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): Required Intervention
• Patient Age: 72 YR