MAUDE Adverse Event Report: LENSAR, INC ALLY ADAPTIVE CATARACT TREATMENT SYSTEM

Model Number N/A

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

Patient Problem Capsular Bag Tear (2639)

Event Date 07/27/2023

Event Type  Injury  

Manufacturer Narrative

Measure: this issue only impacted this specific device.Analyze: cas, reviewed the open call for (b)(6).Case #(b)(6): adequate suction and suction ring placement.No noteworthy movement found throughout the entirety of procedure.1 ak planned, 38-degree arc at axis 97 with radius 4.0.Patient anatomy (eyelid) resulted in poor localized imaging thus aborting ak planned.Laser functioned as designed.Noteworthy lens bag tilt (eye tilt) noted on scheimpflug scans with two scheimpflug scans were blocked due to patient anatomy (nose shadow).Laser functioned as designed completing capsulotomy in frame 12, fragmentation in frame 39, and ak in frame 51.Root cause: laser functioned as designed.Patient head positioning reason for scheimflug scans noting lens bag tilt.No further follow up.

Event Description

On (b)(6) 2023, dr.(b)(6).Reported to cas that she noticed an "anterior leaf rent" during procedure id# (b)(6).She stated that during the ia (irrigation/aspiration) portion of the procedure, she noted a possible rupture due to the flow of the fluid seeming" uneven".She then stated that after removing "half of the nucleus" she noticed the "leaf rent".

• Brand Name: ALLY ADAPTIVE CATARACT TREATMENT SYSTEM
• Type of Device: ALLY ADAPTIVE CATARACT TREATMENT SYSTEM
• Manufacturer (Section D): LENSAR, INC; 2800 discovery drive ste.100; orlando FL 32826
• Manufacturer (Section G): LENSAR, INC; 2800 discovery drive ste. 100; orlando FL 32826
• MDR Report Key: 17611347
• MDR Text Key: 321828823
• Report Number: 3009026057-2023-56986
• Device Sequence Number: 1
• Product Code: OOE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 70-00050-001
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other