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

Model Number DIU300

Device Problems Crack (1135); Mechanical Jam (2983); Material Split, Cut or Torn (4008)

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

Event Date 03/31/2022

Event Type  malfunction  

Manufacturer Narrative

Age, weight and ethnicity: information unknown/ not provided.Per regulation eu (b)(4)(general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Implant date: not applicable, as the lens was not implanted.Explant date: not applicable, as the lens was not implanted; therefore, it was not explanted.Initial reporter - telephone number: (b)(6).Initial reporter - first/given name: unknown/not provided.The intraocular lens (iol) has 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.Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that there was an intraocular lens (iol) defect and that the cartridge tip had burst.Through follow up, it was learned that on (b)(6) 2022, the surgeon went to implant the intraocular lens into the patient's operative eye, used balanced saline solution and the lens got stuck.The surgeon looked down and the cartridge tip had burst.The cartridge tip made contact with the patient's eye, but not the lens.When the surgeon later looked at the optic, he also saw that it was torn.However, the doctor stressed that this lens did not make contact with the patient, as the lens was still stuck in the cartridge.The patient was given a new lens of the same model and diopter and everything went well.Both patient and surgeon are satisfied.The surgeon is unsure if material is still available, but says he will get in touch with the quality team if it is.No other information was provided.

• 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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 14190297
• MDR Text Key: 290561381
• Report Number: 3012236936-2022-01090
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474727601
• UDI-Public: (01)05050474727601(17)241220
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 04/22/2022

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: DIU300
• Device Catalogue Number: DIU300I200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2021
• 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