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 05/23/2023

Event Type  Injury  

Manufacturer Narrative

Measure: this issue only impacted this specific device.Analyze: senior cas reviewed the open call for al23009: case #64 - od.Centration was superior/temporal with good suction applanation to the eye.No movement is noted throughout treatment.Tag defender is noted at 252-degrees from foreign object in bss bath.Capsulotomy is completed at frame #7 with debris in line with capsulotomy pattern.Fragmentation completes at frame #30.Both ak incisions are completed at axis 37-degrees and 217-degrees.Debris in bss bath contributed to incomplete treatment of the capsulotomy.Surgical technique to remove capsulotomy is recommended by clinical staff with use of utrata forceps.Case #65 - os.Centration was superior with minimal suction applanation to the eye.Minor patient eye movement is noted throughout the treatment.Capsulotomy is completed at frame #8.Fragmentation is completed at frame #30.Both ak incisions are completed at axis 160-degrees and 340-degrees.Patient movement during the capsulotomy treatment contributed to weakening of the tissue.Case #69- os.Centration is good with poor suction applanation to the eye.No movement is noted throughout treatment.Capsulotomy is completed at frame #7.Fragmentation is completed at frame #31.Both ak incisions are completed at axis 150-degrees and 330-degrees.Patient has 4 post rk incisions to the cornea.Area at these locations can prevent full treatment to the tissue.Surgeon should use caution when removing the capsulotomy to prevent tears in these areas.Root cause: surgical technique, debris in the bss, patient rk scaring, and movement may have contributed to the tears in the capsulotomy.Follow up: surgeon stated the following day that all post op patients were doing fine with no issues.

Event Description

On (b)(6) 2023 while on site for new surgeon training with dr.Al23009-c21u cas reported on two cases, issues were reported:case # 64 - tag defender noted at 252-degrees.Surgeon proceeded with laser treatment.Cap and fragmentation were treated along with two ak incisions.During the removal phase, a small tear was noted at the area of the tag defender.Tear did not radiate to the posterior and surgery continued with planned lens.Lens haptics were place away from the torn area.Novitrectomy performed.Case #65 - capsular tear at area of 340-degrees with toric nub.No radial tear occurred and planned lens was inserted with no issue.No vitrectomy was performed.Case #69 - patient had post rk incisions on cornea.Surgeon was informed that capsulotomy may be incomplete due to incision scars at those areas.Laser treatment proceeded without issue.Surgeon removed capsulotomy with utrata forceps and remarked tissue adhesions in the four rk incision areas,no tears were noted.

• 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: 17142419
• MDR Text Key: 317307779
• Report Number: 3009026057-2023-55657
• 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: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• 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: 05/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2022
• 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