MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE ALCON MICROSURGICAL INSTRUMENTS, IRRIGATING CYSTITOME; CYSTOTOME

Catalog Number	8065425120
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that an ophthalmic tip was found to be bent in wrong direction.Procedure details and patient impact have not been provided.Additional information has been requested.
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).
Additional Manufacturer Narrative
Additional information is provided in sections d.9, e.1, h.3 and h.6 and h.10.Device history records traceable to the reported procedure pack could not be reviewed.The customer reported that cystotome tip is bent in the wrong direction.The manufacturer's evaluation of the sample confirms the customer's reported event: a microscopic image of the tip of a cystotome confirms the tips to be bent upward.Based on review of the cystotome process and taking into account multiple variables, engineering has observed and determined a potential source for this issue can be related to the raw material cannula supplied by the vendor.In addition, we observed incorrect timing on the forming station causing impacts to the tips.The laser sensor that tells forming(cystotome) station when to actuate ¿ a misalignment here can contact the edge and cause the observed defect.The investigation observed two root causes: defects within the raw material population as well as incorrect timing on the forming station causing impacts to the tips during final production.Manufacturer has taken action to determine root cause and implement appropriate corrective based on observed trend for complaints of a similar nature.To address root causes, the following action was taken; activation of new inspection tool within the existing vision system to mitigate escape of complaint characteristic product.The additional inspection will remove non-conforming product from the population prior to release.Complaints are reviewed and will be continued to be monitored at regular intervals for adverse trends.No further action has been identified for this reported event at this time.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.Custom pak manufacturing management has been made aware of this complaint through the consumer affairs review meeting.The manufacturer internal reference number is: (b)(4).

• Brand Name: ALCON MICROSURGICAL INSTRUMENTS, IRRIGATING CYSTITOME
• Common Device Name: CYSTOTOME
• 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: 15160702
• Report Number: 2523835-2022-00281
• Device Sequence Number: 20257701
• Product Code: HNY
• UDI-Device Identifier: 00380654251202
• UDI-Public: 00380654251202
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2022

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: 8065425120
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (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
• Concomitant Medical Products and Therapy/Usage Dates: CUSTOM-PAK SURGICAL PROCEDURE PACK; UNSPECIFIED CUSTOM PAK
• Patient Sex: Unknown