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 Codes	Eye Injury (1845); Discomfort (2330)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown; requested but not provided.The best estimate date is between 13 july 2022 and 27 sept 2022.Device evaluation: the device was not returned at the manufacturing site, reason unknown; 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 there were no other complaints for this po.No escalation was required.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.Attempts were made to obtain the missing information; however, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the patient required an explant of the intraocular lens (iol) from their left eye.Another johnson and johnson lens (model za9003, +12.5 diopter) was placed as the replacement iol.No vitrectomy or sutures were required.The patient is stated to be fully recovered.No additional information was provided.
Additional Manufacturer Narrative
Corrected data: upon further review, it was noted to update and replace code hm-unspecified injury with hm-sub-optimal results.Hm-sub-optimal results code would apply in this case (unexpected outcome) since explant root cause is being described in the complaint when there is a difference in power (1.5 difference in power) between replacement lens and original lens.Event at this time is assessed and updated to not reportable.There will no longer be any further reporting under mfr report number 3012236936-2022-02610.Fields below updated: section h6l health effect: impact code: 2271, section h6l health effect: clinical code: 2330.Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: 11/7/2022.Section h3: device evaluated by manufacturer¿ yes.Device evaluation: the complaint lens was received inside a different lenses lens case.Visual inspection under magnification was performed and lens damage and haptic damage was observed.The lens was cleaned, and during cleaning the haptic became detached.No further issues were observed.Conclusion: as a result of the investigation there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson and 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: 15642242
• Report Number: 3012236936-2022-02610
• Device Sequence Number: 15046241
• Product Code: HQL
• UDI-Device Identifier: 05050474528895
• UDI-Public: (01)05050474528895(17)260401
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2022

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: 04/01/2026
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030140
• 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: 09/29/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female