MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number DIU150

Device Problems Break (1069); Mechanical Problem (1384); Inaccurate Delivery (2339); Mechanical Jam (2983)

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

Event Type  malfunction  

Manufacturer Narrative

Unknown, not provided.Best estimate sometime in month of july 2021.The device is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that while being inserted into the patient's eye, a diu150 intraocular lens (iol) misfired, it got stuck in cartridge, then the plunger bypassed the the iol.But the doctor was able to take the iol from the simplicity injector and reload into a platinum cartridge, was able to inject the iol safely and complete the case.It was stated that the doctor felt that the deployment issue could have been due to the thickness of the 8.5 d lens.The suspect iol in this event was eventually implanted.The injector and remaining device will not be returned.Product identifiers still unknown.No other information was provided.

Manufacturer Narrative

Corrected data and additional data: upon further review, it was determined, that the event reported in the initial mdr is no longer reportable, since there was no device malfunction or serious injury that occurred.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Corrected data: upon further review, it was noted that d1: brand name was inadvertently entered as tecnis delta in the initial mdr submitted.This correction mdr is to update brand name to tecnis iol.Section d1: brand name: tecnis iol.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 12305284
• MDR Text Key: 266029788
• Report Number: 2648035-2021-08212
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/13/2021

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
• Device Operator: Health Professional
• Device Model Number: DIU150
• Device Catalogue Number: UNK-DIU
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 08/12/2021; 08/13/2021
• Supplement Dates FDA Received: 08/12/2021; 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1MTEC, LOT UNKNOWN; 1MTEC, LOT UNKNOWN