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 11/13/2023

Event Type  Injury  

Manufacturer Narrative

Measure: this issue only impacts this specific device.Procedure id (b)(6) was reviewed.It appears the titanium arm is not locked to the robocone.The suction ring is well centered.There is eye movement throughout the procedure.Eye movement could potentially lead to a capsular tear.No further follow up required.

Event Description

On 11/13/2023, while onsite for sda, dr.(b)(6) reported a posterior radial tear during procedure id # (b)(6).

• 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: 18322216
• MDR Text Key: 330428891
• Report Number: 3009026057-2023-59360
• 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: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• 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: 11/13/2023
• 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