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 Corneal Perforation (1792)

Event Date 08/16/2013

Event Type  Injury  

Manufacturer Narrative

Measure: this issue only impacted this specific device.Analyze: cas oscar cornejo reviewed the open call for (b)(6): case #215 - os, adequate centration with suction applanation to the eye.Moderate eye movement is noted throughout treatment.Capsulotomy firing began in frame 3 with adequate break through.Both ak completed at 151 and 331.Root cause: laser functioned as designed.Patient movement and ak positioning caused penetration of endothelium.

Event Description

On (b)(6) 2023,(b)(6) reported to cas that dr.Had an ak penetrating the endothelium (perforating the posterior of the cornea) on procedure id #(b)(6).No stitches used or further surgical intervention reported.Site is requesting case to be reviewed.

• 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: 17766735
• MDR Text Key: 323642137
• Report Number: 3009026057-2023-57390
• 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: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• 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: 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2022
• 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