MAUDE Adverse Event Report: LENSAR, INC LENSAR LASER SYSTEM-FS 3D

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	03/29/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Measure: this issue only impacted this specific device.Analyze: (b)(6) reviewed the open call for (b)(4): case #: (b)(4) - centration of the eye cup was placed superior.Significant eye movement is noted throughout treatment.Capsulotomy begins at frame #3.At frame #5, cap breakthroughs in nasal area is due to head tilt.Cap completion is noted at frame #6.Fragmentation treatment starts at frame #11 with continued movement of the eye.Two-plane chop pattern extending out to 2.59mm with a single cylinder cut out to 2mm is noted at frame #13.Large bubbles are noted throughout frag treatment moving anterior.Fragmentation is completed at frame #27.First ak is started at frame #30 and second ak is started at frame #42.All treatment is completed at frame #53.Root cause: patient movement and improper locking of the pid arm to the eye cup.Additionally, surgeon technique during hydrodiscection and phaco removal may have contributed to capsule tear during surgical treatment.Laser functioned as designed improve/innovate/control: dr (b)(4) stated that she removed the cap button easily but felt during gentle hydrodisection she didn't get any real bubble release.She rocked the lens gently and rotated it freely with not a lot of bubbles coming up.As she went to place a groove in center of the lens for a divide and conquer technique it dropped to the back of the eye immediately.The lens was retrieved by a retina colleague at the facility and a pars plana vitrectomy was done.A sulcus iol was able to be placed.At day 1 the patient appeared to be doing okay.No previous eye surgeries or injuries were noted.
Event or Problem Description
(b)(4) issue: on (b)(6) 2022, (b)(6) ((b)(4)) reported to (b)(6) that dr.(b)(6) had a what appeared to be a "very large bubble" (b)(4).(b)(6) stated that the bag collapsed as soon as dr.(b)(6) went into the eye.Site is requesting that the case be reviewed.

• Brand Name: LENSAR LASER SYSTEM-FS 3D
• Common Device Name: LENSAR LASER SYSTEM-FS 3D
• 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
• Manufacturer Contact: keith peck ; 2800 discovery drive ste. 100; orlando, FL 32826 ; 8885756412
• MDR Report Key: 14218570
• Report Number: 3009026057-2022-00013
• Device Sequence Number: 14487601
• Product Code: OOE
• UDI-Device Identifier: 10867744000119
• UDI-Public: (01)10867744000119(11)200303
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K182795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 70-00013-001
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown