MAUDE Adverse Event Report: DEROYAL INTERCONTINENTAL, S.R.L SURG EYE SPEARS-10/PK-10PK/CS, SURG EYE SPEARS-10/PK-10PK/CS; SPONGE, OPHTHALMIC

Model Number	30-049
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Codes	Eye Injury (1845); Foreign Body Reaction (1868)
Date of Event	12/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An end consumer reported, "eye spears shed fibers that became a foreign body in eye causing severe inflammatory reaction.Dr hovander had to redo the whole procedure with amniotic membrane incurring additional expense." deroyal has requested return of the device, but has not yet received it.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report when additional information becomes available.
Event or Problem Description
An end consumer reported, "eye spears shed fibers that became a foreign body in eye causing severe inflammatory reaction.Dr hovander had to redo the whole proceduure with amniotic membrane incurring additional expense.".
Additional Manufacturer Narrative
Deroyal requested return of the device, but never received it.Deroyal reviewed failure mode and effect analysis (fmea) and corrective actions and preventive actions (capas) and no issues were found.An inventory check was completed on the (b)(4) each of the sponges and all were found to be acceptable.Maintenance logs were checked on the cutter press machine.All maintenance logs were up to date and showed that the machines were clean.There was some wear noted on one of the rubber mats.A complaint to sales ratio was conducted between january of 2022 to february 2024 and was found to be (b)(4).Root cause: because no sample was able to be obtained, the issue was not able to be confirmed.Corrective or preventive actions: while no root was established, a discussion was had with an operator to ensure the process of cutting the eye spear was followed to eliminate any excess particles from the eye spear.The cutting board and the rubber on the eye spear cutting machine were replaced.The process is 100% visually inspected.This process was observed and the operator confirmed that any irregular cuts or any loose particles are removed during inspection.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
Additional Manufacturer Narrative
Deroyal requested return of the device, but never received it.However, pictures of the device were provided to deroyal.When reviewing the pictures received, it was noted that threads could be seen coming out of the eye spears indicating that a clean-cut was not made.Deroyal reviewed failure mode and effect analysis (fmea) and corrective actions and preventive actions (capas) and no issues were found.An inventory check was completed on the (b)(4) each of the sponges and all were found to be acceptable.Maintenance logs were checked on the cutter press machine.All maintenance logs were up to date and showed that the machines were clean.There was some wear noted on one of the rubber mats.A complaint to sales ratio was conducted between (b)(6) of 2022 to (b)(6) 2024 and was found to be (b)(4).Root cause: based on the investigation performed and the verification with the pictures, the root cause was determined to be a manufacturing issue in that the operator did not see or remove excess particles from the eye spear.Corrective or preventive actions: while no root was established, a discussion was had with an operator to ensure the process of cutting the eye spear was followed to eliminate any excess particles from the eye spear.The cutting board and the rubber on the eye spear cutting machine were replaced.The process is 100% visually inspected.This process was observed and the operator confirmed that any irregular cuts or any loose particles are removed during inspection.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: SURG EYE SPEARS-10/PK-10PK/CS, SURG EYE SPEARS-10/PK-10PK/CS
• Common Device Name: SPONGE, OPHTHALMIC
• Manufacturer (Section D): DEROYAL INTERCONTINENTAL, S.R.L; km 7 autopista joaquin balague; pisano free zone bldg 49; santiago, ; DR
• Manufacturer (Section G): MEDSORB DOMINICANA, S.A.; zona franca industrial park; san pedro de marcoris, ; DR
• Manufacturer Contact: reagan newman ; 1703 highway 33 south; new tazewell, TN 37825 ; 8653622106
• MDR Report Key: 19951978
• Report Number: 3004605321-2023-00006
• Device Sequence Number: 8784824
• Product Code: HOZ
• UDI-Device Identifier: 50749756023929
• UDI-Public: 50749756023929
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2024

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 Model Number: 30-049
• Device Lot Number: 58092155
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 08/09/2024; 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown