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 07/07/2023

Event Type  Injury  

Manufacturer Narrative

Measure: this measure only impacts this specific device.Analyze: cas, (b)(6) reviewed the open call for al23012.Case#: (b)(4) - suction ring placement is well centered with adequate suction holding throughout the procedure.The capsulotomy begins in frame #3 full breakthrough in frame #9.Lens fragmentation follows.Mild patient movement is noted during the capsulotomy.The scheimpflug scans reveal a very bright anterior cornea which could be a result of the betadine drops that were instilled into the patient eye before the start of the procedure.Root cause: a noticeable bright anterior cornea caused by the betadine drops instilled into the eye before the start of the procedure could cause the "scatter effect" when the capsulotomy is cutting resulting in a weakened capsulotomy.Laser functioned as designed.No further follow up.

Event Description

On (b)(6) 2023, while cas was on-site (al23012-c21u), dr.Reported a radial tear for procedure #61.The tear was noticed during the cortex removal, and it was located opposite of his main incision (inferior nasal).Dr.Reported a second radial tear in the same area (inferior nasal) for procedure #62.Dr.Was able to proceed with planned lens and no further intervention was needed.

• 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: 17555386
• MDR Text Key: 321225695
• Report Number: 3009026057-2023-56694
• 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: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• 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: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2023
• 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