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 07/19/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, while cas was on-site (b)(6), dr.Noticed an anterior capsular tear during procedure #32.The tear was in the superior area near the main incision.

Manufacturer Narrative

Measure: this issue only impacts this specific device.Analyze: cas, (b)(6) reviewed the open call for (b)(6).Procedure #32 - left eye: suction ring placement is well centered with adequate suction holding throughout the procedure.Minimal patient movement is noted.Capsulotomy begins in frame #3 with full breakthrough in frame #8.This is followed by fragmentation and ak #1 at an axis of 285.Root cause: patient anatomy contributed to bag movement during laser treatment, resulting in an incomplete treatment.Laser functioned as designed.No further follow up.

• 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: 17571903
• MDR Text Key: 321417700
• Report Number: 3009026057-2023-56792
• 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: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• 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: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2023
• 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