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

Model Number	DIB00
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Material Fragmentation (1261); Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If explanted, give date: not applicable as the lens remains implanted.Device evaluation: the product testing could not be performed as the product was not returned (the lens remains implanted).The reported complaint cannot be confirmed.Manufacturing record evaluation: the manufacturing records for the device 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 specifications.A search in complaint system revealed no other complaints have been received for this production order number.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency and the reported event cannot be confirmed.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the haptic of an intraocular lens (iol) got stuck under the push bar and ripped the haptic as it was being pulled out of the injector.The doctor had to go inside the eye and amputate the distal end of the stuck haptic from the injector.The edge was smooth and therefore the decision was made to continue implanting the iol in the bag and the lens was left in the right eye of the patient without a haptic.It was indicated that after insertion, they could not get the injector out, because the haptic was under the push bar.The surgery tech thinks that at the time of manufacturing when the lenses are loaded, the back haptic trails back.The lens with only one haptic remains implanted as of to date and no secondary surgical procedure has been performed.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer: yes.Section d9: date returned to manufacturer: nov 30, 2021.Section h3: device evaluated by manufacturer: yes.Device evaluation: a piece of the complaint lens was received in the original simplicity handpiece.The original folding carton was also received.A piece of detached haptic from the complaint lens was received overridden and stuck in the cartridge of the simplicity handpiece.The handpiece was disassembled and no defects or assembly issues were observed.A damaged plunger rod tip was observed which implies excessive force was used during deployment.The haptic detached issue was confirmed, however this can be attributed to using an inadequate amount of ophthalmic viscoelastic device (ovd) during loading and insertion (implied by very trace amount of viscoelastic residue in the cartridge) which can contribute to deployment issues and therefore cannot be confirmed to be related to manufacturing and no product deficiency could be 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: 12913638
• Report Number: 3012236936-2021-00171
• Device Sequence Number: 4820543
• Product Code: HQL
• UDI-Device Identifier: 05050474731905
• UDI-Public: (01)05050474731905(17)240817
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2024
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• 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: 11/04/2021
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2021
• 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 Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Hispanic