MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC; CANNULA, OPHTHALMIC

Catalog Number	8065149525
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample has been received and in-house evaluation is in progress.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).
Event or Problem Description
A customer reported that an ophthalmic soft tip cannula was being used to inject intravitreal corticosteroid injection into the patient's eye during a surgery.The tip was trimmed and it was primed prior to use.While injecting, the soft tip portion of the cannula was ejected into the eye and was subsequently removed from the eye during the same procedure.There was no patient harm.
Additional Manufacturer Narrative
One opened soft tip cannula in a plastic container with the blister and no cap on cannula within a bag was received for the report of the soft tip cannula was ejected into the eye and was removed.The sample was visually inspected and was nonconforming, the soft tip was detached from the cannula.There was a presence of adhesive in the cannula.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The photos attached to the parent complaint were reviewed by the manufacturing site.The photos are of a cannula missing a soft tip and a tyvek label, the reported product complaint, product and lot information is confirmed.The returned non-conforming sample was received opened.How and when the soft tip of the cannula became ejected (detached) cannot be determined from this evaluation, however, the evaluation shows that the presence of adhesive on the cannula and most likely was detached during use.A root cause cannot be determined for the complaint as described by the customer.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.All assemblies are 100% inspected for the soft tip during the manufacturing process to ensure that the product meets release acceptance criteria.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.4no adverse trends have been observed associated with the reported product and event.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: ALCON MICROSURGICAL INSTRUMENTS, CANNULA OPHTHALMIC
• Common Device Name: CANNULA, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15462173
• Report Number: 2523835-2022-00355
• Device Sequence Number: 3050806
• Product Code: HMX
• UDI-Device Identifier: 00380651495258
• UDI-Public: 00380651495258
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2022

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 Catalogue Number: 8065149525
• Device Lot Number: 145WHW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/24/2022
• Supplement Date Received by Manufacturer: 11/21/2022
• Initial Report FDA Received Date: 09/21/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2021
• 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: UNSPECIFIED CUSTOM PAK
• Patient Age: 58 YR
• Patient Sex: Male