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

Model Number	550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Type of Reportable Event	Serious Injury
Additional 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.Alcon lensx (site #(b)(4)) is no longer operational.Lensx manufactured products are maintained and investigated by the alcon research, ltd.Irvine technology center (site #(b)(4)).The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported during post phacoemulsification of the extremely hard nucleus, the pupil was closed and non-responsive.Rupture of capsule occurred due to cortical aspiration with miosis.Vitrectomy performed and surgery was rescheduled.Patient's symptoms were resolved.
Additional Manufacturer Narrative
A review of the device history record traceable to the reported lot number, indicates that the product was processed and released according to the product¿s acceptance criteria.The root cause could not be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: LENSX LASER SYSTEM
• Common Device Name: OPHTHALMIC FEMTOSECOND LASER
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 11752210
• Report Number: 1644019-2021-00295
• Device Sequence Number: 4138119
• Product Code: OOE
• UDI-Device Identifier: 00380659982255
• UDI-Public: 380659982255
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K123120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 550
• Device Catalogue Number: 8065998225
• Device Lot Number: 2389326H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR