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

Model Number	DIB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable as the iol was inserted and removed within the same procedure.If explanted, give date: not applicable as the iol was inserted and removed within the same procedure.The device was not returned for evaluation as it was discarded.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 the missing information.However, to date it has not been received.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was noticed to be damaged after it was implanted in the left eye.The iol was removed and replaced within the same procedure with a backup of the same model and diopter.The suspect iol was discarded and therefore will not be returned.There was no injury reported and no medical intervention such as incision enlargement, vitrectomy or sutures.Reportedly, post-operatively the patient is doing excellent.No further information was provided.
Additional Manufacturer Narrative
Corrected data: in review, it was noticed that for the section "h3" of the initial mdr report, the option "(other (code unspecified, describe in h10) (81)" should have been selected and the box "not returned to manufacture" should have been check which inadvertently they were not.In review, it was also noticed that an incorrect verbiage was inadvertently used in sections d6a & d6b of the initial mdr report.Therefore, this supplemental mdr report is being submitted to correct that information.The following fields were updated accordingly: section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same procedure.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: mar 3, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: the plunger rod damage (bent tip) was observed consistent with excessive force during delivery.Cartridge damage (bulge) was also observed.No additional defects or assembly issues were observed before and after disassembly for evaluation.Lens testing could not be performed as the iol was not returned.An image of the reported event was provided and evaluated.The image displays a tear that looks to be towards the leading portion of the lens.It is likely that this issue occurred while the lens was being advanced from the module to the cartridge.It is probable that the cause was due to the leading edge of the lens becoming stuck during the advancement process, causing the lens to tear.However, no further investigation could be performed without evaluation of the lens.Conclusion: based on the investigation, no malfunction or product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• Brand Name: TECNIS SIMPLICITY
• Common Device Name: 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: 16433327
• Report Number: 3012236936-2023-00234
• Device Sequence Number: 7449807
• Product Code: HQL
• UDI-Device Identifier: 05050474731608
• UDI-Public: (01)05050474731608(17)250903
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/03/2025
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female