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

Model Number	DIB00
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the intraocular lens (iol) cracked when trying to load it.Reportedly, the loading issue occurred during the handling of the product.There was no patient contact with the device.No further information was provided.
Additional Manufacturer Narrative
If implanted give date: not applicable as the lens was not implanted.If explanted give date: not applicable as the lens was not explanted.Initial reporter email address: unknown/not provided.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 have been made to obtain the missing information.However, it was not available.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Additional Manufacturer Narrative
Section a2 age/date of birth: date of birth is (b)(6) 1952 and age is 70.Section a3 gender: female.Section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: sep 6, 2022.Section h3: evaluated by manufacturer: yes device evaluation: visual inspection under magnification of the complaint handpiece revealed that it was received with the plunger rod advanced into the cartridge.The cartridge tip could be observed to be cracked and the cartridge neck could be observed to be damaged.The handpiece was disassembled and the assembly was inspected, no assembly issues were identified.The complaint lens was removed from the tape and cleaned.Revealing that the edge of the lens was chipped.A similar chip could also be identified on the haptic.A product quality deficiency could not be determined.The complaint issue " dc-lens 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 observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Conclusion: as a result of the investigation there is no indication of a product deficiency or product malfunction.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: 15255732
• Report Number: 3012236936-2022-02064
• Device Sequence Number: 6720801
• Product Code: HQL
• UDI-Device Identifier: 05050474731684
• UDI-Public: (01)05050474731684(17)240423
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 10/13/2022

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: 04/23/2024
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0165
• 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: 07/27/2022
• Supplement Date Received by Manufacturer: 09/25/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2021
• 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: 70 YR
• Patient Sex: Female