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 02/16/2024

Event Type  Injury  

Manufacturer Narrative

Debris on the underside of the window could contribute to an incomplete capsulotomy therefore increasing chance of capsulotomy tear.No further medical intervention.

Event Description

P1008 - n/a - issue: on 02/16/2024, dr (b)(6) reported to cas that during procedure id #(b)(4), he experienced a radial tear.He noted that the capsulotomy button was easy to remove.Site is seeking review of the procedure.

• 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: 18897028
• MDR Text Key: 337585645
• Report Number: 3009026057-2024-00011
• 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: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• 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: 02/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2023
• 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