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

Model Number	DIB00
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) cartridge tip was placed into the right eye but the lens was not implanted because the cartridge tip was bent.There was no damage to the haptic or optic of the iol.Per the surgeon's documentation, the main wound was "slightly damaged" but suturing was not needed.No additional medical or surgical intervention was required.Per the surgeon¿s note, the replacement lens (same model and diopter) was placed without any issues.No further information was provided.
Additional Manufacturer Narrative
Section d6a: if implanted, give date: not applicable, as the lens was not implanted.Section d6b: if explanted, give date: not applicable, as the lens was not implanted, therefore not explanted.Section h3-other (81): 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.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: the product was received for evaluation.Additional information was received stating ¿defective¿.The correct spelling of the first name of the surgeon (initial reporter), "marshall", was also received.No further information was provided.Correction: based on the additional information received, it was discovered that a typo was reported on the initial mdr for section e1, initial reporter first/given name, which was reported as marshal, but should be marshall.This supplemental report is capturing this corrected information.The following sections/fields have been updated accordingly: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: jul 18, 2023.Section e1: first/given name:(b)(6).Section h3: evaluated by manufacturer: yes.Device evaluation: product evaluation was performed under magnification.The complaint device presented with a lens stuck in the cartridge tip and the plunger rod overriding the lens.The cartridge tip and cartridge were observed to be cracked.The handpiece assembly was inspected and no issues were identified.The lens was removed and presented damaged and torn.The complaint issue of ¿cartridge tip cracked/damaged¿ was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.The other issues observed during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: as per complaint investigation results, the product was released within specifications.The complaint issue reported could not be confirmed and no product deficiency or product malfunction 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: 17087822
• Report Number: 3012236936-2023-01435
• Device Sequence Number: 12279356
• Product Code: HQL
• UDI-Device Identifier: 05050474731578
• UDI-Public: (01)05050474731578(17)251007
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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: 10/07/2025
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0110
• 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: 05/16/2023
• Supplement Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2022
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Race: White