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

Model Number	ZA9003
Medical Device Problem Codes	Material Fragmentation (1261); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient complained of vision days after the intraocular lens (iol) was implanted.Upon returning to the operating room, believing that the issue was just a need to reposition the lens, the doctor identified that one of the iol handles had come loose.When the doctor got instruments into the capsular bag, the other strap came loose as well.The doctor performed the total explant (loops and optic zone), and the patient was left aphakic, with a new surgery scheduled at a later date to implant a new lens.It was noted that the iol was explanted in a secondary procedure.Through follow-up, it was learned that the lens was used for yamane scleral fixation surgery on the right eye.The yamane fixation surgery was quick and uneventful.In the 30-day postoperative period, it was found that one of the haptics had come loose from the lens body.The patient denies trauma or ocular itching during the postoperative period.The implant surgery was (b)(6) 2022.The secondary surgery where the lens was removed and the eye was left aphakic was on (b)(6) 2022.Prior to the implant surgery, the patient was already aphakic without capsular support and ¿vitrectomized¿ before the patient was referred to the surgeon¿s office.The patient experienced low visual acuity since a few days before the appointment on (b)(6) 2022.The patient will have another lens implanted ninety days from the date of removal, which will be (b)(6) 2023.The patient is currently aphakic and awaiting further iol implant surgery.The doctor noted that the fixation of the haptics in the iol in this case was not normal.No further information was provided.
Additional Manufacturer Narrative
Patient weight and ethnicity: unknown; requested but not provided.Reporter name and address: telephone number: (b)(6).Health effect - clinical code: (b)(4).Medical device problem code: (b)(4).Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed, and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.A search of complaints related to this production order (po) was performed.The search revealed that no similar complaint for this po number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Upon further review, it was determined that the event should be coded as health effect - impact code 4629 - device revision or replacement, not health effect - impact code 4627 - device explantation, which was originally reported on the initial mdr.Therefore, this supplemental report is to capture this corrected information.The following fields have been updated accordingly: section h6: health effect - impact code 4629 - device revision or replacement all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
The product was received for evaluation.Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: dec 5, 2023.Section h3: evaluated by manufacturer: yes.Device evaluation: the lens was received inside of a syringe with an unknown solution.Visual inspection of the lens found that it was cut in half with both haptics detached; one haptic was damaged near the edge.No further evaluation was performed, and no further issues were identified.The complaint issue "haptic detached" 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.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• 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: 15771322
• Report Number: 3012236936-2022-02789
• Device Sequence Number: 17429371
• Product Code: HQL
• UDI-Device Identifier: 05050474529014
• UDI-Public: (01)05050474529014(17)270226
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2024

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 Model Number: ZA9003
• Device Catalogue Number: ZA90030200
• 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: 10/17/2022
• Supplement Date Received by Manufacturer: 02/07/2024; 03/15/2024
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 02/12/2024; 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Race: White