MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER PUREPOINT LASER; LASER, OPHTHALMIC

Catalog Number 8065750597

Device Problem Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2017

Event Type  malfunction  

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.(b)(4).

Event Description

A nurse reported that a laser probe would not fit into the cannula during a procedure.The procedure was completed.There was no patient harm.

Manufacturer Narrative

The customer reported that the laser probe could not be inserted into the cannula.The surgery was completed by using another laser probe.There was no patient impact.A 23ga illuminated flexible curved tip laser probe with radio frequency identification (rfid) was received and a visual assessment of the returned sample showed no obvious nonconformities.The laser probe was inserted into a 23ga trocar cannula, but light resistance could be felt near the cannula-nitinol junction.The laser probe tip was measured using the 23ga needle length gauge, and were found to meet company specifications.The sample¿s outer cannula diameter (od) was measured and found to meet specifications.A close inspection of the od revealed that cannula did meet od specifications.It should be noted that the laser probe tip cannula is visually inspected during manufacturing that checks for no burrs, sharp or jagged edges on the cannula or nitinol tube using a magnification eye loupe.The laser probe, (l/n (b)(4) was manufactured on november 7, 2016.There were 372 paks associated with this lot.A review of the manufacturing records in online preliminary record review application (oprra) did not reveal any related non-conformity during manufacturing for this product.Based on qa assessment, the product met specifications at the time of release.A review of complaints for the last 24 months did not indicate any additional related reports for this laser probe lot number.The product was found to meet specifications, therefore, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: PUREPOINT LASER
• Type of Device: LASER, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 6721650
• MDR Text Key: 80430515
• Report Number: 2028159-2017-03086
• Device Sequence Number: 1
• Product Code: HQF
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K062624
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2020
• Device Catalogue Number: 8065750597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR