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 09/11/2023

Event Type  Injury  

Event Description

P1008 - n/a -issue: on (b)(6) 2023, while cas was on site, dr.(b)(6) noticed two run-offs in the capsulotomies.Procedure id #(b)(4) run off was in the inferior region and procedure id #(b)(4) was in the superior region.

Manufacturer Narrative

Measure: this issue only impacts this specific device.Analyze: (b)(6) reviewed the open call for al23012.Case #(b)(4) - the titanium arm can be seen moving throughout the procedure indicating that it was not seated correctly allowing for patient eye movement.In addition, the anterior corneal surface is extremely bright.This indicates increased scatter which will attenuate not only the sld energy delivered to the lens but the laser energy for performing the capsulotomy.It was confirmed that the site uses a pre-operative betadine wash which will increase the scatter at the anterior surface.Case #(b)(6) - the titanium arm can be seen moving throughout the procedure indicating that it was not seated correctly allowing for patient eye movement.In addition, the anterior corneal surface is extremely bright.This indicates increased scatter which will attenuate not only the sld energy delivered to the lens but the laser energy for performing the capsulotomy.It was confirmed that the site uses a pre-operative betadine wash which will increase the scatter at the anterior surface.Root cause: unknown.

• 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: 17872833
• MDR Text Key: 324943253
• Report Number: 3009026057-2023-57936
• 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: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• 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: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2023
• 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