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

Model Number	DIB00
Medical Device Problem Codes	Break (1069); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the preloaded intraocular lens (iol) possibly had a bent/ broken haptic.Account indicated that the leading haptic was protruding too far.The lens was inserted into the patient's left eye; however, the surgeon was unable to seat the lens properly.The iol was removed from the eye.Another lens of the same model and diopter power was placed without any incident.The original iol was discarded.No further information was provided.
Additional Manufacturer Narrative
Implant date: if implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Explant date: if explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.The device was not returned for analysis as it was discarded.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, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: following information was obtained from the patient label received along with the sample at the investigation label: section a2: date of birth: (b)(6)1956.Section b5: the first name of the surgeon was (b)(6).Section d9: device available for evaluation: yes section d9: returned to manufacturer on: jul 13, 2022 section h3: device evaluated by manufacturer: yes device evaluation: the product was returned to the manufacturing site for evaluation.No iol was received as part of this return, therefore no product evaluation could be performed on the lens.Visual inspection under magnification of the handpiece revealed that it was received with the plunger rod fully advanced.The cartridge tip could be observed to be bent, in a way consistent with a handpiece that was dropped.The external assembly was inspected and, no issues that could cause or contribute to positioning issues during implantation could be identified.Conclusion: the reported complaint issues could not be confirmed, therefore cold not be confirmed to be related to a manufacturing or design issue.As no lens was returned 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: 14951356
• Report Number: 3012236936-2022-01793
• Device Sequence Number: 5396312
• Product Code: HQL
• UDI-Device Identifier: 05050474731547
• UDI-Public: (01)05050474731547(17)240419
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2022

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: 04/19/2024
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0095
• 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: 06/14/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2021
• 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: 65 YR
• Patient Sex: Female