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

Model Number	ZA9003
Medical Device Problem Codes	Break (1069); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an intraocular lens (iol) was implanted and explanted.No further information was provided.
Additional Manufacturer Narrative
Age, weight, ethnicity: unknown, information not provided.If explanted, give date: unknown, information not provided.Initial reporter street address, city and zip code: unknown/information not provided.Device evaluation: product evaluation was not performed because the product has not been returned.The complaint issue reported could not be verified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search revealed that no other complaints have been received from this production order.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.Attempts have been made to obtain 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
Corrected data: per additional information received, it was clarified that the lens was removed and replaced during the same procedure due to significant tilt into the eye as lens was damaged due to use error.Product is discarded.The following fields have been updated: section b1: malfunction.Section h6: added code 4631 in health effect - impact code.Added code 4581 in health effect - clinical code.Added codes 2923, 1069 in medical device problem code.Additional information received: section a2: 59 yrs.Old, date of birth: (b)(6) 1962.Section a3: male.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: 13103748
• Report Number: 3012236936-2021-00278
• Device Sequence Number: 4718580
• Product Code: HQL
• UDI-Device Identifier: 05050474529014
• UDI-Public: (01)05050474529014(17)250909
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 01/21/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2025
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030200
• 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: 11/30/2021
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2020
• 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: 59 YR
• Patient Sex: Male