MAUDE Adverse Event Report: LENSAR, INC ALLY ADAPTIVE CATRACT 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 01/16/2024

Event Type  Injury  

Manufacturer Narrative

The suction ring in the procedure is locked properly.Laser completed capsulotomy with little to no patient movement.During fragmentation a large gas bubble forms behind the lens.There is no indication the laser did not function as designed.Anterior vitrectomy performed and 3-piece lens placed.

Event Description

P1008 - posterior capsular rupture issue: on (b)(6) 2023, ginger powell ((b)(6)) reported to jessica byer that dr.(b)(6) had a posterior rupture on case #(b)(4).Anterior vitrectomy performed and 3-piece lens placed.

• Brand Name: ALLY ADAPTIVE CATRACT TREATMENT SYSTEM
• Type of Device: ALLY ADAPTIVE CATRACT 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: 18730487
• MDR Text Key: 335764157
• Report Number: 3009026057-2024-00006
• Device Sequence Number: 1
• Product Code: OOE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182795
• 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: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• 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: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2014
• 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