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 12/29/2023

Event Type  Injury  

Manufacturer Narrative

Procedure id 49 shows good suction ring centration and no eye movement during procedure.The cap looked uniform during breakthrough.Scheimpflug scans show some reflectivity on the corneal surface.There is also some debris on the window noted.Procedure id 50 was reviewed and there was corneal interruption of laser treatment due to previous refractive surgery (rk) this could have caused adhesions around the capsulotomy.Procedure id 51 shows a decentered suction ring and minimal eye movement through the procedure.The capsulotomy and fragmentation appear to have been completed without issue, it is unknown what could cause the posterior tear.No further clinical follow up.

Event Description

P1008 - tags/incomplete capsulotomy - issue: on (b)(6) 2023, dr.(b)(6) reported to cas that dr.Noted capsular tags on procedure ids #49 and #50; and a posterior tear on procedure id #51(post rk patient).

• 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: 18552553
• MDR Text Key: 333361921
• Report Number: 3009026057-2024-00002
• 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: 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• 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: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2023
• 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