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

Model Number	DIB00
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a, patient information: a4, a5: information unknown/asku.Section d6a, if implanted, give date: not applicable as the iol was removed and replaced during the same procedure.Section d6b, if explanted, give date: not applicable as the iol was removed and replaced during the same procedure.Section h3-other (81): 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, information was not available.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the johnson and johnson (jnj) intraocular lens (iol) had a scratch.The iol was fully inserted into the patient¿s left eye.Upon insertion the lens was noticed to have a ¿spot¿ which customer clarified to be a scratch on the lens.The lens was removed and replaced in the same procedure due to a scratch, divet or defect in the center of the iol.The replacement lens is the same model and diopter.There were no complications such as a vitrectomy, sutures, or incision enlargement.The outcome does not interfere with activities of daily life.Iol is not available for return as it was discarded.No further information was provided or is available.
Additional Manufacturer Narrative
Correction.This is to correct the initial submission section h6 health effect ¿ impact code.It incorrectly reported 2199 =no health consequences or impact.The code should not have been included.Additional information.Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: jun 15, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: the product was received and evaluated.A "scuff" mark was observed on the posterior of the iol.The inspection of all assembly related items revealed no anomalies.No assembly issues were 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 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: 16925025
• Report Number: 3012236936-2023-01033
• Device Sequence Number: 7033174
• Product Code: HQL
• UDI-Device Identifier: 05050474731592
• UDI-Public: (01)05050474731592(17)250904
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

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: 09/04/2025
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0120
• 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: 04/24/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2022
• 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: 55 YR
• Patient Sex: Female