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 02/26/2024

Event Type  Injury  

Event Description

P1008 - n/a issue: on 02/26/2024, while (b)(6) was on site for sda at (b)(6), dr.(b)(6) reported that he had a radial tear on id # (b)(6), the tear was located at the inferior temporal os.Additional surgical intervention was not required.

Manufacturer Narrative

Laser capsulorhexis was completed without issue and laser found to have functioned as designed.Additional surgical intervention was not required.

• 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: 18972049
• MDR Text Key: 338547930
• Report Number: 3009026057-2024-00015
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• 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: 02/26/2024
• 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