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

Model Number	DCB00
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) was implanted into the patient's operative eye, however; it was removed from the eye as it was missing a haptic.Another lens of same model and diopter was used as the replacement iol.No further information was provided.
Additional Manufacturer Narrative
Unknown, information not provided.If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.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 definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: received following information from the patient stickers received along with the sample: section a2: age/date of birth: jan 2, 1954, 68 years.Section a3: gender: female.Section b5: the eye affected was right eye.Section e1: reporter name: dr.(b)(6).Section e3: occupation: physician.Section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: may 12, 2022.Section h3: device evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed that the lens was received with the lens stuck inside of the cartridge tip and overridden by the plunger rod.The lens was removed and cleaned, revealing that both haptics were detached and the iol had been torn, suggesting that the haptics were torn from the lens during insertion.Inspection of the handpiece revealed that the cartridge tip was damaged and that one of the detached haptics was still stuck inside of the cartridge.The handpiece was disassembled and the assembly was inspected, no assembly issues were identified.Conclusion: the reported complaint issue 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.Therefore, 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: 14293542
• Report Number: 3012236936-2022-01201
• Device Sequence Number: 5524087
• Product Code: HQL
• UDI-Device Identifier: 05050474636194
• UDI-Public: (01)05050474636194(17)241002
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2022

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: 10/02/2024
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000255
• 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: 04/12/2022
• Supplement Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2021
• 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: 68 YR
• Patient Sex: Female