MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; CATARACT TENAYA SURGERY CENTER

Model Number	VAL009CATEA
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported, "blue fibers in the custom pack are evident on the instruments within the pack.Fibers have been found in the eye as well." specifically mentioned, "it was inside the eye, on top of the lens and was removed with utrada forceps, (b)(6) 2021 by md." additional emails received by facility representatives, (b)(6), who provided additional information in regards to this reported incident.Reporters confirm incident occurred (b)(6) 2021.Reporter states, "product was not thoroughly inspected prior to use; issue was identified during procedure." "physician noticed lint in patient's eye and on instruments." per initial complaint report, lint removed with utrada forceps by physician that day ((b)(6) 2021).Reporter states, "no serious injury, follow-up care or medical intervention needed." no additional general anesthesia or sedation was needed or provided after the reported incident.Reporter states, "no adverse events reported during post-op phone call." no samples are available for return and evaluation.Photograph sent.No further information has been provided.Due to the reported incident, medical intervention and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported, "blue fibers in the custom pack are evident on the instruments within the pack.Fibers have been found in the eye as well." specifically mentioned, "it was inside the eye, on top of the lens and was removed with utrada forceps, (b)(6) 2021 by md.".
Additional Manufacturer Narrative
D9 device available for evaluation -n/a g6 type of report - follow-up.H2 if follow-up what type? additional information.H3 device evaluated by manufacturer - n/a h6 type of investigation- 3331, 4110, 4112, 4119 h5 investigation conclusion - zcd00005/defect confirmed: unknown responsible party h10 investigation report reads as follows: 05/11/2021 15:26:40 cst ((b)(6) )."sample evaluation: a photo was received for our investigation.Photo shows a long fiber / thread found in eye under magnification.Cannot identify the particulate is blue.Not certain when photo was taken during or post-surgery.Finished good production records reviewed: review of production assembly instructions shows 20-gauge needle, eye spears and instrument wipe are left inside of vendors packaging.Syringes and tega-derm are placed with components inside of a poly bag.There is no direct contact with drapes, gowns or liner of low lint btc.No cotton towels are used in pack.Without lot information for pack, we cannot pull or review production records.Finished good pack build reviewed: review of the bom shows a low lint btc is used for this pack.Trending:trending was reviewed and there have been 1 additional reported complaint(s) for this issue in the past 6 months.Investigation summary: the account reported finding blue fibers in the pack.The reported issue occurred in item val009catea (lot unknown).Based on the photo and information in this complaint we were able to determine a true root cause as the original source of the particulate could not be identified.".
Event or Problem Description
It was reported, "blue fibers in the custom pack are evident on the instruments within the pack.Fibers have been found in the eye as well." specifically mentioned, "it was inside the eye, on top of the lens and was removed with utrada forceps, 3/17/21 by md.".

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: CATARACT TENAYA SURGERY CENTER
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11752484
• Report Number: 1423395-2021-00021
• Device Sequence Number: 3223694
• Product Code: OJK
• UDI-Device Identifier: 10889942872398
• UDI-Public: 10889942872398
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2021

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 Model Number: VAL009CATEA
• Device Catalogue Number: VAL009CATEA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention