MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER LENSX LASER SYSTEM; OPHTHALMIC FEMTOSECOND LASER

Model Number 550

Device Problems Mechanical Problem (1384); Air/Gas in Device (4062)

Patient Problem Capsular Bag Tear (2639)

Event Date 07/01/2012

Event Type  Injury  

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

Event Description

A literature article reported a patient experienced an anterior capsular tear that extended to the posterior pole during sculpting.During laser assisted portion of the cataract surgery, an air bubble was noticed in the periphery of the patient interface.Prior to removal of the cataract, the capsulotomy was seen to be incomplete.A capsular tear developed during aspiration of the nucleus.Incomplete section was completed manually.Entire nucleus was noted to be moving forward immediately prior to the tear.It was not clear if the phacoemulsification tip inadvertently caught the capsule during this movement or whether the tear occurred as a result of the forward pressure of the nucleus itself.A secondary procedure was performed to remove lens fragment and intraocular lens (iol) was placed in the sulcus.There are multiple related reports associated with this literature article.This report addresses patient three and other manufacturer reports will be filed.

Manufacturer Narrative

Corrected information provided in b.2.Additional information provided in d.10., and h.10.There is no exact event date.The literature article event dates took place from (b)(6) 2012 to (b)(6) 2017.Literature article is attached to this report.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

After review of reported event as well as related literature, there is no evidence indicating that the integrity of the posterior capsule was compromised by the performance of the system.The root cause of the reported event could not be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: LENSX LASER SYSTEM
• Type of Device: OPHTHALMIC FEMTOSECOND LASER
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 11372528
• MDR Text Key: 233300272
• Report Number: 2028159-2021-00199
• Device Sequence Number: 1
• Product Code: OOE
• Combination Product (y/n): N
• PMA/PMN Number: K163551
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 550
• Device Catalogue Number: 8065998162
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION VISION SYSTEM; INFINITI VISION SYSTEM; CENTURION VISION SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR