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

Model Number DIU100

Device Problems Break (1069); Contamination (1120); Mechanical Problem (1384); Device Difficult to Setup or Prepare (1487); Use of Device Problem (1670)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/01/2022

Event Type  malfunction  

Event Description

It was reported that when the plunger pushed the preloaded intraocular lens (iol), a resistance was felt when screwing in the plunger.When the plunger was screwed further, there was a fragment of the lens optic being introduced into the anterior chamber.The rest of the iol was stuck in the cartridge as the plunger overrode the iol.The plunger tip and broken fragment were removed from the patient's eye.There was a 10 minute delay in procedure.No medical or surgical intervention was required.Vision pre-operative: 6/12 and vision post-operative: 6/6.No further information was provided.

Manufacturer Narrative

Patient information cannot be provided due to personal data privacy legislation/policy.Implant date: not applicable, as lens was not implanted.Explant date: not applicable, as lens was not implanted.Initial reporter name and address: telephone number (b)(6).The device was not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation 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.

Manufacturer Narrative

Corrected data: section h6: in the initial report medical device problem code 1120 was provided.However, the code was inadvertently provided and is not reflective of the initially reported event.In further review the appropriate code for the reported event is 1670 - use of device problem and 1069 - break.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information and corrected data: additional information was received that the event occurred due to use error.Therefore, this event is no longer reportable and no further information will be provided under mfr report number 3012236936-2023-00023.

• 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
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 16108656
• MDR Text Key: 308632229
• Report Number: 3012236936-2023-00023
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474725683
• UDI-Public: (01)05050474725683(17)250122
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2023

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: DIU100
• Device Catalogue Number: DIU100I125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/05/2023
• Supplement Dates Manufacturer Received: 03/20/2023; 03/20/2023
• Supplement Dates FDA Received: 03/23/2023; 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male