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

Model Number	550
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.3., h.6.: 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 the manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A non healthcare professional reported plastic thread glued attached to the base of patient interface came in contact with patient's left eye during cataract surgery.
Additional Manufacturer Narrative
Additional information provided in h.3., h.6., and h.11.The investigation conducted a non-conformance review of the reported lot number.No deviations, were identified and all corresponding production release specifications defined in the device master record were met.' multiple low image resolution images appear to show splatter of some type of substance onto the patient interface lens.Based on the images alone, we are unable to ascertain the identity and origin of the lens substance and/or object.Loctite curing process was incomplete causing light splatter of loctite onto the patient interface lens from the bonded port.The root cause of the customer's complaint could not be conclusively determined as product was not returned and the condition of the product could not be verified.The image provided by the customer was assessed but no failure mode could be ascertained from the image.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• Brand Name: LENSX LASER SYSTEM
• Common Device Name: OPHTHALMIC FEMTOSECOND LASER
• Manufacturer (Section D): SPECIALTY SILICONE FABRICATORS (TRELLEBORG); 2761 walnut ave; tustin CA 92780
• Manufacturer (Section G): SPECIALTY SILICONE FABRICATORS (TRELLEBORG); 2761 walnut ave; tustin CA 92780
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 22217645
• Report Number: 1644019-2025-01891
• Device Sequence Number: 12799085
• Product Code: OOE
• UDI-Device Identifier: 00380659981630
• UDI-Public: (01)00380659981630(17)251231(11)240213(10)16JLC7
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K101626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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 Expiration Date: 12/31/2025
• Device Model Number: 550
• Device Catalogue Number: 8065998163
• Device Lot Number: 16JLC7
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LENSX LASER SYSTEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female