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

Model Number	DCB00
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a monofocal intraocular lens (iol) was explanted due to mechanical complications which the lens was dislocated.The doctor tried to reposition the lens, but was unable to do so; therefore, decided to remove the lens.The incision was enlarged, a vitrectomy was done, and a non-johnson & johnson sulcus lens of 16.5 diopter was implanted in the patient¿s right eye.Reportedly, the patient tolerated the procedure well.The lens is not being returned as it was discarded.No further information was provided.
Additional Manufacturer Narrative
Section b3: date of event: unknown, not provided, but the best estimate date is between (b)(6) 2023 and (b)(6) 2023.Section h3-other (81): the device was not returned for evaluation 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.Section h6: health effect - impact code: 4625 - unplanned vitrectomy; 4625 - secondary surgical intervention section h6: health effect - clinical code: 4581 - this code was used for the reported device decentered or dislocated or tilted subluxated or wrong position an attempt has been made to obtain missing information; however, the information has not been provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: the following fields were updated based on the additional information received from the customer: section b5: additional information received from the customer indicated that the date which the mechanical complication/lens dislocation issue first noted is unknown.Also, it was confirmed that there was a capsule tear which required an unplanned vitrectomy to be performed.Section h10: health effect - clinical code: 2639 - capsular bag tear.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: in review, it was noticed that the date (jun 13, 2023) was entered in the section d6a and also mentioned in the verbiage for b3 in the section h10 of the initial mdr report which is incorrect.The correct date that should have been entered is "jul 13, 2023"; therefore, the information has been corrected in this supplemental mdr report and the following fields were updated accordingly: section b3: date of event: unknown, not provided, but the best estimate date is between jul 13, 2023 and aug 24, 2023.Section d6a: if implanted, give date: (b)(6) 2023 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: 17760696
• Report Number: 3012236936-2023-02379
• Device Sequence Number: 20525092
• Product Code: HQL
• UDI-Device Identifier: 05050474636026
• UDI-Public: (01)05050474636026(17)260126
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/26/2026
• Device Model Number: DCB00
• Device Catalogue Number: DCB0000170
• Was Device Available for Evaluation?: No
• 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: 08/24/2023
• Supplement Date Received by Manufacturer: 09/20/2023; 10/18/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 10/10/2023; 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White