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

Catalog Number	8065149530
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 customer reported that ophthalmic soft tips were not fitting into trocars.Patient and procedure were not reported.No patient harm was reported.
Additional Manufacturer Narrative
Samples were visually inspected and found to be conforming.A dimensional inspection for cannula od was performed and was found to be conforming.Functional fit test was performed with both samples and soft tip was able to be inserted into a lab supplied trocar.A review of the device history record traceable to the possible lot numbers indicates that the product was processed and released according to the product¿s acceptance criteria.The photo attached to the parent file was reviewed by the manufacturing site.Photo shows a package with reported lot number.Reported issue cannot be confirmed from photo.The returned unopened samples were found to be visually, dimensionally and functionally conforming, therefore the product complaint as described by the customer was not confirmed.However, since the actual complaint samples were not returned, a root cause cannot be determined for the complaint as described by the customer.Because the actual complaint samples were not returned the exact root cause for this complaint is unknown, specific action with regards to this complaint cannot be taken.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 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: 18483921
• Report Number: 2523835-2024-00024
• Device Sequence Number: 13031111
• Product Code: HMX
• UDI-Device Identifier: 00380651495302
• UDI-Public: 00380651495302
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/29/2024

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: 8065149530
• Device Lot Number: 161E1V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2023
• Supplement Date Received by Manufacturer: 05/01/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 05/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2023
• 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 Sex: Unknown