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 06/20/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, dr.((b)(6)) reported an anterior capsular tear during procedure #(b)(6).

Manufacturer Narrative

Measure: this issue only impacted this specific device.Analyze: senior cas (b)(6) reviewed the open call for (b)(6): case #(b)(4)- os, centration is superior with minimal suction applanation to the eye.Capsulotomy starts at frame #3 and completes at frame #8.Fragmentation starts at frame #13 and completes at frame #30.Single ak incision at 166-degrees is completed without issue.Minor patient eye movement is noted throughout procedure.Laser functioned as designed.Root cause: patient anatomy shows scaring or damage around 15-degrees.This anomaly may have prevented full laser treatment of the capsulotomy during treatment.This area is also in line with the surgical incision.A weak capsulotomy treatment due to patient anatomy may contribute to an anterior tear.No further follow up required.

• 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: 17350284
• MDR Text Key: 319293866
• Report Number: 3009026057-2023-56191
• 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: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• 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: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2022
• 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