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

Model Number 550

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Retinal Detachment (2047)

Event Date 04/05/2020

Event Type  Injury  

Manufacturer Narrative

H.3., h.6.: 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.The manufacturer internal reference number is: (b)(4).

Event Description

A healthcare professional reported via investigation study, the patient suffered traumatic retinal detachment in an unidentified eye, occurring two months after undergoing cataract surgery.

Manufacturer Narrative

All device history records are reviewed prior to product release to ensure the product was manufactured in compliance with the device master record and meets release criteria.Based on the information obtained, the root cause of the reported event is inconclusive.The manufacturer internal reference number is: (b)(4).

• 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: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18766004
• MDR Text Key: 336052185
• Report Number: 2028159-2024-00279
• Device Sequence Number: 1
• Product Code: OOE
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K163551
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 550
• Device Catalogue Number: 8065998162
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other