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

Model Number	ZA9003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight: unknown/asked but unavailable.Date implanted: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.Date explanted: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.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.(b)(4) eye anatomy issue,, (b)(4) incision enlargement.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported after the intraocular lens (iol) was inserted into the patient's ocular sinister (left eye) the doctor did not think it would hold.The iol was removed and no lens was implanted.The incision was enlarged and suture(s) were required.Through follow-up, additional information was received confirming the patient did have prior eye history that contributed to the event, 2x retinal surgery prior to iol implant.There was no product quality issue that contributed to the event.Patient outcome post-procedure was reported as fine.The patient has surgery scheduled with a retina surgeon.No further information is available.
Additional Manufacturer Narrative
Product investigation was completed, and the following fields were updated accordingly: section d-9: device available for evaluation: yes.Section d-9: date returned to manufacturer: 23-may-2022.Section h-3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the lens was received with a cut to the optic body.The lens was cleaned and, no issues that could contribute to anatomy issues were identified.A chip on the edge of the lens could be identified.The complaint issues were not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: based on the investigation results, there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.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: 14342735
• Report Number: 3012236936-2022-01218
• Device Sequence Number: 12083343
• Product Code: HQL
• UDI-Device Identifier: 05050474528918
• UDI-Public: (01)05050474528918(17)260117
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• 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): 08/02/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2026
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030150
• 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: 04/21/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EMERALD CARTRIDGE LOT # UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White