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

Model Number	DIB00
Medical Device Problem Codes	Break (1069); Failure to Fold (1255)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as there was no indication that the lens was implanted.If explanted, give date: not applicable, as there was no indication that the lens was implanted, therefore not explanted.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.
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) unraveled before implantation.There was patient contact.It was noted that the lens was not removed/replaced in the same procedure nor was it removed in a secondary procedure.There was no delay in procedure.No suture, incision enlargement, or vitrectomy was required.There is no planned explant.Lens damaged was noted in the source email.No further information was provided.
Additional Manufacturer Narrative
The product was received for evaluation.Additional information was received on a patient implant card which reported that the affected eye was the left eye and the surgeon (reporter) was dr.(b)(6), telephone number: (b)(6).Implant date of(b)(6) 2022 was also reported, however, based on all the information received, it is unclear if the lens was actually implanted.This date was originally reported on the initial mdr as the date of event.The following sections have been updated accordingly.Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: may 25, 2023.Section e1: reporter name and address: title (e.G., mr., ms.): dr.Section e1: reporter name and address: first/given name: (b)(6).Section e1: reporter name and address: last name: (b)(6).Section e1: reporter name and address: telephone number: (b)(6).Section e2: health professional? yes.Section e3: occupation: physician.Section h3: evaluated by manufacturer: yes.Device evaluation: no intraocular lens (iol) was received.Visual inspection under magnification revealed that the complaint handpiece was received with the plunger rod advanced to the cartridge tip.The cartridge tip and cartridge could be observed to be stretched (out of round); however, the stretching observed is within expected parameters for a used cartridge.The handpiece was disassembled and the assembly was inspected, no issues that could cause or contribute to the complaint or observed stretching could be identified.The complaint issue "lens damaged and lead haptic not folded¿ was not confirmed during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to the manufacturing or design process.Conclusion: based on the 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.Correction: based on the additional information received, section e1 reporter name and address, which was originally reported as melinda reeves, has been corrected to dr.Jennifer jordan.This supplemental report is being submitted to capture this correction.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: 16577079
• Report Number: 3012236936-2023-00699
• Device Sequence Number: 4681683
• Product Code: HQL
• UDI-Device Identifier: 05050474731851
• UDI-Public: (01)05050474731851(17)250719
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/11/2023

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: 07/19/2025
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0245
• 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: 02/24/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 03/20/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2022
• 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: Male