MAUDE Adverse Event Report: LUMENIS, INC. SELECTA DUET; POWERED LASER SURGICAL INSTRUMENT

Model Number SELECTA DUET

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Macular Edema (1822)

Event Date 05/09/2018

Event Type  Injury  

Manufacturer Narrative

A user facility reported that one (1) patient developed a macular edema in the right eye following a yag capsulotomy procedure with a lumenis selecta duet system.It was further reported that pred forte was prescribed for post-operative management.Lumenis investigated the reported event by contacting the user facility to obtain patient information, treatment settings and patient photos which were provided by the user facility.An examination of the subject device by a lumenis technical expert concluded, after verifying all system functions including calibration and energy output verification that the subject device operated within manufacturer's specifications.No device malfunction was reported or observed.Subject device malfunction is not the cause of the reported event.A lumenis healthcare professional spoke with the user facilities physician directly over the phone and reviewed the reported event.The following conclusions were noted; 1.In yag mode, direct damage to the retina is prevented by the large cone angle of the treatment beam (16 degree) and by plasma formation posterior to the site of optical breakdown.The only way a treatment beam could cause direct retinal damage is if the laser was used in slt mode.Since the physician confirmed that the laser was used in yag mode at all times, this possibility can be ruled out.2.As noted in the operator manual, there are known risks involved in yag laser posterior capsulotomy.Some of these risks include cystoid macular edema (cme), which could be relevant to the current incident.In several clinical studies, the incidence of cme was up to 2%.Cme could be caused by various mechanisms, including vitreous liquefaction and traction.Retinal detachment, which was also observed in up to 2% of cases, could trigger retinal breaks - also relevant to this case.3.One of the key factors for a successful yag capsulotomy free of retinal complications is protection of the anterior hyaloid face.Anterior hyaloid damage (ahd) during yag capsulotomy is associated with a range of retinal complications, including macular edema, retinal breaks, retinal holes, and retinal detachment.In one study, the rate of ahd was close to 20%.The authors noted that "ahd may be due to high pulse energy, high pulse number, carelessness, time limitations, issues related to focus of the beam on the posterior capsule, or inexperience".While pulse energy/pulse number are adequate, and carelessness/time limitations/inexperience are not likely, "issues related to focusing of the beam on the posterior capsule" could be relevant to this case.See the next bullet point.4.In this incident, the yag posterior capsulotomy was performed without a contact lens.While some physicians with extensive experience do perform this procedure with no contact lens, one should keep in mind that the use of a contact lens is important for many reasons, two of which could be relevant to this case: i.Optimizing the view of the posterior capsule: one of the key factors in anterior hyaloid disruption (ahd) is focusing the yag beam too posteriorly.Use of a contact lens, to obtain a clear view of the posterior capsule, could minimize this risk.Ii.Stabilization of the eye: inadvertent movements of the eye, especially rapid saccades, are much faster than the reaction time of a typical physician.Eye movement during lasing can damage non-target ocular tissues, for example (but not limited to) the anterior hyaloid face.Use of a contact lens, here as well, could minimize this risk.A review of the dhr confirmed that the system device met all test specifications without deviation per the dhr during the manufacturing process.

Event Description

A user facility reported that one (1) patient developed a macular edema in the right eye following a yag capsulotomy procedure with a lumenis selecta duet system.It was further reported that pred forte was prescribed for post-operative management.

• Brand Name: SELECTA DUET
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): LUMENIS, INC.; 1870 south milestone dr.; salt lake city UT 84104
• Manufacturer (Section G): LUMENIS, INC.; 1870 south milestone dr.; salt lake city UT 84104
• Manufacturer Contact: gary buzzell ; 2077 gateway place; suite 300; san jose, CA 95110 ; 4087643008
• MDR Report Key: 7695614
• MDR Text Key: 114220165
• Report Number: 1720381-2018-00003
• Device Sequence Number: 0
• Product Code: HQF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081704
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SELECTA DUET
• Device Catalogue Number: GAS910000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR