MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; EYE CATARACT PK

Catalog Number DYNJ46557K

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2023

Event Type  Injury  

Manufacturer Narrative

The customer reported, on (b)(6)2023 "cystotome was being used during a procedure and it cracked while in the eye.The customer reported the piece was removed with forceps and the incident prolonged the procedure time.According to the customer, the patient is "ok as far as we are aware".A sample has been requested for evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

Cystotome cracked while in the eye.

• Type of Device: EYE CATARACT PK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16949937
• MDR Text Key: 315423288
• Report Number: 1423395-2023-00021
• Device Sequence Number: 1
• Product Code: OJK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYNJ46557K
• Device Lot Number: 23AMJ164
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other