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

Model Number	PCB00
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Inaccurate Delivery (2339)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	10/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age, weight, ethnicity: unknown/ information not provided.If implanted, give date: not applicable, as lens was removed during the same procedure.If explanted, give date: not applicable, as lens was removed during the same procedure.Initial reporter last name: unknown/information not provided.Address: unknown/information not provided.Email address: unknown/information not provided.Initial reporter telephone number: (b)(6).The device was not received therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending 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 or Problem Description
It was reported that the doctor encountered issue with the injector on the main preloaded intraocular lens (pcb00).There was problem with the loading and delivery of the lens into patient's eye.The doctor then proceeded with a 3-piece (za9003) lens insertion and found that the lens haptic broke once it was injected into the patient's eye.The 3-piece lens was then removed from the patient's eye and the patient was left aphakic.The doctor informed that the patient will need to have a 3-piece lens for sulcus implantation as a replacement lens.Based on additional information received, the preloaded lens was difficult to use as the movement of the lens forward to the cartridge tip was not smooth.It was stuck and then the lens plunged forward which caused a posterior capsule rupture in the patient.The lens was fully inserted into the capsular bag but pierced through the bag due to the faulty delivery mechanism.It was then removed.Only the lens made contact with the patient's eye.No further information was provided.This emdr report pertains to the event with the pcb00 preloaded intraocular lens.A separate report was already submitted for the event related to the za9003 3-piece intraocular lens.
Additional Manufacturer Narrative
Corrected data: in review, it was noted that the product investigation for the device and the information which indicated that "the doctor had to extend the wound slightly, cut up the lens and remove it" was inadvertently not included in the initial mdr report.Therefore, the information has been captured in this supplemental mdr report and the following fields were updated accordingly: section h3: device evaluated by manufacturer: yes.Section h6: health effect - impact code: 4625 -incision enlarged.Section h6: type of investigation: 4109 - historical data analysis.Section h6: type of investigation: 3331 - analysis of production records.Section h6: investigation findings: 213 - no device problem found.Device evaluation: the product testing could not be performed as the product was not returned for evaluation.The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed and no non-conformance report (nc) was found as part of this manufacturing records review.The product was manufactured and released according to specification.A search in complaint system revealed that two additional complaints were received for this production order number; however, these complaint issues reported were not related; therefore, no escalations were required.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes.Date returned to manufacturer: jan 8, 2022.Device evaluation: visual inspection of the handpiece, revealed trace amounts of viscoelastic residue inside of the cartridge.The external assembly was inspected, and presented with no issues.Visual inspection, of the lens, under magnification revealed viscoelastic residue on the optic body and haptics and that the lens was received with a cut on the optic body.The lens was cleaned, and presented with no further issue (other than being cut).The complaint issue could not be confirmed, and no product deficiency could be identified.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• 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: 13015475
• Report Number: 3012236936-2021-00194
• Device Sequence Number: 4741733
• Product Code: HQL
• UDI-Device Identifier: 05050474558137
• UDI-Public: (01)05050474558137(17)220813
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/13/2022
• Device Model Number: PCB00
• Device Catalogue Number: PCB0000135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2022
• 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: 11/19/2021
• Supplement Date Received by Manufacturer: 12/15/2021; 02/22/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 12/16/2021; 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female