MAUDE Adverse Event Report: SPECIALTY SILICONE FABRICATORS (TRELLEBORG) LENSX LASER SYSTEM; OPHTHALMIC FEMTOSECOND LASER

Model Number	550
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.Nine opened patient interfaces (pi¿s) were returned and visually inspected.The tubing was found partially detached from the cone assembly.Adhesive residue was observed in the suction ring ports and on the tubing, however, based on the condition of the detached tubing, it appeared insufficient adhesive was used to attach the tubing to the cone assembly.The root cause is related to the manual application process of adhesive to the bonded joints during assembly of the tubing to the cones.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported during flap procedure, the patient interface (pi) released vacuum approximately half way through the procedure.The operation was stopped and it was decided to not continue with the refractive part of the treatment.Additional information received stated there was no patent harm.The patient will probably have additional treatment to complete the flap in three to four weeks.

• Brand Name: LENSX LASER SYSTEM
• Common Device Name: OPHTHALMIC FEMTOSECOND LASER
• Manufacturer (Section D): SPECIALTY SILICONE FABRICATORS (TRELLEBORG); 2761 walnut ave; tustin CA 92780
• MDR Report Key: 11516401
• Report Number: 1644019-2021-00167
• Device Sequence Number: 4046925
• Product Code: OOE
• UDI-Device Identifier: 00380659981630
• UDI-Public: 00380659981630
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: K101626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: 550
• Device Catalogue Number: 8065998163
• Device Lot Number: 2339481H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR