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

Catalog Number	8065441720
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 physician reported that during a cataract surgery an ophthalmic cannula came and liquid could not pass.Surgery was completed by alternate product.There was no report of patient harm.
Additional Manufacturer Narrative
Additional information is provided in sections d.9,h.3,h,6 and h.10.One opened cannula in a blister within a bag was received for the report of the cannula came without a lumen and no liquid passes.The cannula was visually inspected and found to be nonconforming, the cannula id at the tip was occluded with foreign material.The sample was sent for particulate analysis, the foreign material was analyzed using fourier transform infrared (ft-ir) and comparison to the ir spectra to the library of spectra finds the best match to be protein.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 two cannulas in blisters and a pak label, the reported product and lot information is confirmed.The reported product complaint could not be confirmed from the photos.The complaint evaluation confirms the presence of foreign material in the id of the cannula.The particle analysis found that the foreign material occluding the cannula best match to be protein.Protein is not a material used in the manufacturing and packaging process of the cannula.How and when the cannula became occluded with protein cannot be determined from this evaluation and a root cause cannot be determined for the complaint as described by the customer.The most likely source of the foreign material is from surgical material.No specific action with regard to this complaint was taken because the root cause for the complaint issue cannot be determined from this evaluation.An acceptance quality limit (aql) sampling is performed to ensure that the product meets release acceptance criteria.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.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: 15791714
• Report Number: 2523835-2022-00421
• Device Sequence Number: 14858500
• Product Code: HMX
• UDI-Device Identifier: 00380654417202
• UDI-Public: 00380654417202
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2023

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: 8065441720
• Device Lot Number: 14LF62
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2022
• 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
• Patient Age: 49 YR
• Patient Sex: Female