MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number LXT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 08/05/2020

Event Type  Injury  

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

A customer reported that during a cataract procedure, the patient's anterior chamber shallowed after hydrodissection.A viscoelastic was injected into the eye, and upon phacoemulsification, a thermal injury occurred.Three corneal sutures were required.The procedure was completed without further incident.

Event Description

Additional information was provided by the surgeon, who reported the cataract hardness was a grade 2, in the right eye.The patient is currently being treated with a corticosteroid eye drop.

Manufacturer Narrative

Additional information provided ina.1., a.2., a.3., b.5.B.6., and d.11.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in h.6.And h.10.A video was submitted for review of the corneal burn.When the video begins, the eye is already prepped for surgery with the speculum in place.The patient can be seen looking around.To provide clarity on the sound for this video, it can be confirmed that there is no audible surgical noises.It is unknown, if the surgeon heard the bell during the case.The surgeon placed #1 paracentesis at the three (3) o¿clock hour and another paracentesis at the eight (8) o¿clock hour.Ophthalmic viscoelastic device (ovd) can be seen entering the anterior chamber (ac) through #1 paracentesis.The patients¿ pupil moves slightly toward the #1 paracentesis incision.More ovd is placed for space in the ac.Balance salt solution (bss) is placed over the cornea for hydration and can be seen entering the eye through the paracentesis #1 incision.Forceps steady the eye and the surgeon completes the manual capsulotomy.Toothed forceps steady the eye again for the main incision creation at the five (5) o¿clock marker.More ovd enters the eye, but seems be placed inside the capsulotomy ridge, also.The surgeon attempts to place the sleeved phaco tip inside the main incision, which gets caught on the sleeve.The incision is very tight and the surgeon has to use the toothed forceps to open the wound slightly to allow the sleeve to pass though the incision opening.Immediately upon the start of the surgeon making the first groove into the cataract, a corneal burn appears and the ovd inside the eye starts to go milky.The phacoing continues as the cornea begins to get more opaque with time.The contents of the materials being aspirated can be seen through the sleeve and it is thick and full of bubbles.The surgeon removes the phaco tip, while still allowing the bss to flow from the tip.The liquid flows against the burnt tissue.The tissue pulls away in a semi-circle and the right side of the semi-circle floats away with the bss rinse.The iris can be seen moving toward the incision and then the surgeon attempts to re-hydrate the main incision.Upon attempting this, the tissue on the left side of the semi-circle floats away with the bss rinse.The cornea can be seen quite rippled, because of the burn.The surgeon uses forceps to open the main incision again and the phaco tip re-enters the eye.The surgeon digs into the cataract and begins to emulsify the material.The anterior chamber can be seen shallowing and then trampolining while the emulsification continues.The surgeon works by spinning the lens in the capsule until it has all been emulsified.The phaco tip is removed from the eye.The irrigation/aspiration (i/a) enters via the main incision and removes the content that remain in the capsulotomy bag.The surgeon can be seen cutting the rest of the burnt corneal tissue away from the main incision.Bss is placed over the cornea and in the ac.The intraocular lens implant (iol) is placed into the ac followed by the i/a to polish.Both paracentesis incisions are hydrated.A weck can be seen at the main incision to removing excess fluid and allowing the surgeon to check for wound leakage when the burn exists.The leakage is confirmed and a single suture is place in the center of the burn tissue and the surgeon tried three (3) times to tie off the suture unsuccessfully.The suture is then removed.Another suture is attempted, this time at the edge of the corneal burn (centrally).This suture is successful.A second suture is placed to the left of the first.A third suture is placed to the right.A weck is used to test for wound leakage.The wound leakage is again confirmed.The third suture is removed and replaced.Another weck is used to test integrity of the wound seal.This time the wound is sealed.Edema can be seen at the limbal zone from ten (10) o¿clock to three (3) o¿clock hours.The surgery is completed with a sub conjunctival injection.Although the substance and specific location cannot been determined.As this occurs just off frame before the video ends.No information on service record (sr) was provided.Two system serial numbers were provided however, it is unclear which system was involved.Therefore, manufacturing information could not be obtained.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in h10.Two serial numbers were provided however, it is unclear which system was involved.However, both system's were noted to have met specifications at the time of release.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 10451798
• MDR Text Key: 204334168
• Report Number: 2028159-2020-00674
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/11/2021

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
• Device Operator: Health Professional
• Device Model Number: LXT
• Device Catalogue Number: 8065751550
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/25/2020
• Supplement Dates Manufacturer Received: 09/11/2020; 12/18/2020; 02/10/2021
• Supplement Dates FDA Received: 09/30/2020; 12/18/2020; 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANTERIOR PAK,1.1,W/O PROBE/IL; ASSY,SHIP,HANDPIECE OZIL-JAPAN; TS TIP,45K,MINI ABS 0.9MM
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR