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	02/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Measure: this issue only impacted this specific device.Analyze: senior cas michael rosenbaum reviewed the open call for (b)(4): case #(b)(6) - centration was superior/ nasal with adequate suction.Software determined the lens density pattern to be a category 1.Ak #1 was planned at 171-degrees with capsular toric markers.Capsulorhexis breaks through at frame #3 with double cuts noted through the pattern.Superior completion is noted at frame #6 due to eye tilt.Fragmentation starting at frame #14 with completion at frame #36.Ak is started at frame #37 with a single pass.Minor eye movement is noted throughout treatment.Safety clearances are set at 1mm posterior to the lens fragmentation.Double cuts of the capsulorhexis can weaken the structure of the incision and integrity of the lens bag.Case #(b)(6) - centration was inferior with poor suction applanation.Software determined the lens density pattern to be a category 3.Ak #1 at 97-degrees and ak #2 was planned at 277-degrees and with a sweep of 24-degrees.Ak #1 was skipped because of area of placement accompanied with the angle of the cornea due to eye tilt.Capsulorhexis break through at frame #3 is incomplete.Excessive patient movement is noted throughout treatment.Safety clearances are set at 1mm posterior to the lens fragmentation.The combination of a dense lens, the incomplete treatment, capsulorhexis and patient movement likely cause the bag to weaken and rupture.Improve/innovate/control: cas katie will discuss findings with surgeon and staff.
Event or Problem Description
P1008 - posterior tearsissue: dr.(b)(6) from (b)(6) center (b)(4) reported to (b)(6) from (b)(6) reported to (b)(6) on 02/07/2022 that on (b)(6) 2022 two cases had irregular caps both cases had posterior tearsresulting in vitrectomy.Patient id (b)(6) and (b)(6).The site was closed down due to weather and reported the issue today.

• 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: 13602508
• Report Number: 3009026057-2022-00011
• Device Sequence Number: 17585565
• Product Code: OOE
• UDI-Device Identifier: 00867744000112
• UDI-Public: 010086774400011211200917
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/07/2022

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: 02/07/2022
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2020
• 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