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

Model Number	DCB00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It as reported that the intraocular lens (iol) was cracked.The iol was fully inserted.The issue was identified during implantation.No vitrectomy or suture was required.Through follow-up it was learned that the lens came cracked.In this case, there was no handling of the lens by the doctor.There was no patient injury and no medical or surgical intervention was required."the result is flat, there are no complaint from the patient.The concern of the doctor is the crack increasing and impacting the patient's vision over time or the lens becoming opaque." ¿result is flat¿ means that the lens corrected the patient's degree.No further information was provided.
Additional Manufacturer Narrative
Age, weight, ethnicity: unknown; requested but not provided.If explanted, give date: not applicable, as the lens remains implanted.Initial reporter: telephone number: (b)(6).The device was not returned for evaluation as it is still implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of two photos, 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 & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information section h3: device evaluated by manufacturer: yes device evaluation: the device was not returned for evaluation; however, two photographs were received.The pictures provided by the customer were evaluated.It shows a pseudophakic eye implanted with an intraocular lens claimed to be a tecnis monofocal 1-piece iol with simplicity model dcb00.A lineal/diagonal mark can be observed at lens mid periphery, which apparently does not involve the central lens and measures approximately 2 mm.The actual location (anterior or posterior lens surface) cannot be determined from picture assessment.Further evaluation could not be performed.The root cause of the reported event as well as its potential clinical impact cannot be determined from a picture assessment.The complaint issue lens damaged could not be confirmed.However, the observed cosmetic issues is similar to the complaint issue lens damaged and could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.As a result of the investigation there is no indication of a product quality deficiency.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: 16313547
• Report Number: 3012236936-2023-00274
• Device Sequence Number: 6279418
• Product Code: HQL
• UDI-Device Identifier: 05050474636217
• UDI-Public: (01)05050474636217(17)251105
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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
• Report Date (Section B): 03/09/2023

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: 11/05/2025
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000265
• Was Device Available for Evaluation?: No
• 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: 01/13/2023
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2022
• 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 Sex: Unknown