MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; EYE SPEAR IN EYE II

Model Number DYNJS0120

Device Problem Material Fragmentation (1261)

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

Event Date 07/26/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that, during cataract surgery, the eye spear component was noted to be "disintegrating" and that eye spear material was noted on the patient's eye.When the reported product problem/issue was identified, the eye spear material was removed from the patient's eye via an unspecified method and no further incident was reported.No adverse patient impact and no further medical intervention or follow-up care was reported.A sample of six (6) unused eye spears were returned for evaluation.The white tips of the eye spear components were observed to be frayed with rough cut edges and small pieces of the white material sticking out and loosely attached.It was noted that, with very little force applied, the small loose pieces could be easily detached from the rest of the eye spear component.Trending was performed and no additional complaints related to this product problem/issue were identified in the last six (6) months.The eye spear component is received from (b)(4) medical inc.In supplier packaging and is not altered during pack assembly.The root cause was determined to be an error in the summit medical inc.Manufacturing process and the supplier was notified of the product problem/issue.Due to the reported need for medical intervention to remove the eye spear material from the patient's eye, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the eye spear component was linting material during use.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: EYE SPEAR IN EYE II
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 12331086
• MDR Text Key: 268676379
• Report Number: 1423395-2021-00037
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10080196927159
• UDI-Public: 10080196927159
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJS0120
• Device Catalogue Number: DYNJS0120
• Device Lot Number: 21DDA980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Date Manufacturer Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention