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

Model Number	DIB00
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.The device 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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) was prepped by the technician with no issues.The lens was inserted, in the right eye, by the surgeon when a scratch down the middle of the lens was noticed.The iol was cut into pieces and removed.Another iol of the same model and diopter was inserted with no issues.There was no reported issue with the lens sticking or advancing during implantation; however, the surgeon said there was a little resistance during insertion.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: 7/13/2022.Section h3: device evaluated by manufacturer¿ yes.Device evaluation: the product was returned to the manufacturing site for evaluation.The complaint lens was received inside of a specimen cup.The complaint handpiece was received loose in a bag.A patient sticker was received as well.Visual inspection under magnification revealed that the complaint lens was received cut into three pieces.The pieces were cleaned and, one piece was observed to be scratched.No further issues were identified.Visual inspection of the handpiece revealed that it was received with the plunger rod fully advanced.The external assembly of the handpiece revealed that there were no gaps that could contribute to the difficulty of use.The plunger rod could also be observed to be bent, in a way consistent with a handpiece that was dropped.All pertinent information available to johnson and 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: 14891296
• Report Number: 3012236936-2022-01731
• Device Sequence Number: 14724893
• Product Code: HQL
• UDI-Device Identifier: 05050474731677
• UDI-Public: (01)05050474731677(17)240515
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/22/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/15/2024
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0160
• 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: 06/13/2022
• Supplement Date Received by Manufacturer: 08/14/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2021
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White