MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS SIMPLICITY; INTRAOCULAR LENS

Model Number DIB00

Device Problems Break (1069); Device Difficult to Setup or Prepare (1487); Mechanical Jam (2983); Scratched Material (3020)

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

Event Date 08/22/2022

Event Type  malfunction  

Event Description

Customer reported when implanting a tecnis simplicity intraocular lens (iol), they noticed that the injector plunger started to push the lens to a certain point where it stopped and did not slide forward any further.The doctor felt resistance when trying to push the lens and saw that it was apparently stuck and had been scratched.At this moment, the doctor tried to open the cartridge to remove the lens from behind, to try not to damage it further, but he could not open the cartridge.He looked for another lens with at least a similar degree in stock, but he didn't have it.In order not to leave the patient aphakic, the doctor ended up opting to try to insert the same lens.When he visualized the lens already in the patient's eye, he noticed two cracks of considerable size.There was a delay in procedure, but no vitrectomy required.The patient did not seek medical attention and the medication prescribed was standard postoperative medication.The patient status is unknown.The device is not available for return.It was noted that direction for use where followed.No further information provided.

Manufacturer Narrative

If explanted, give date: not applicable, there is no indication that the lens was explanted.Telephone number, (b)(6).The intraocular lens (iol) 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.An attempt has been made to obtain missing information; however, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

Manufacturer Narrative

Corrected data: upon further review, it was realized that the event should not have been reported due to the issue being caused by user error and as the reported event was not due to the lens product problem or malfunction.Therefore, the event is no longer reportable and no further information will be provided under this manufacturer report number 3012236936-2022-02690.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Type of Device: INTRAOCULAR LENS
• 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: 15681983
• MDR Text Key: 307169167
• Report Number: 3012236936-2022-02690
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474655454
• UDI-Public: (01)05050474655454(17)250207
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 11/08/2022

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: DIB00
• Device Catalogue Number: DIB00I0225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/27/2022
• Supplement Dates Manufacturer Received: 10/27/2022
• Supplement Dates FDA Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• 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: 80 YR
• Patient Sex: Male