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	Visual Impairment (2138)
Date of Event	07/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient required an explant of the intraocular lens (iol) due to refractive surprise.Account indicated that no vitrectomy was required and no medication was prescribed.The patient is stated to be fully recovered.No additional information was provided.
Additional Manufacturer Narrative
Unknown; requested but not provided.Device evaluation: product testing could not be performed since the lens was not returned for evaluation.Therefore; the reported issue could not be verified, and product quality deficiency could not be determined.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 additional complaints were received 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.
Additional Manufacturer Narrative
Corrected data/additional information: new information was received that the replacement lens was za9003 20.5d, sn (b)(6).Upon further review, this event is now determined to be not reportable.Therefore, there will no longer be any further reporting under mfr report number 3012236936-2022-02363.Section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: 9/20/2022.Section h3: device evaluated by manufacturer¿ yes.Device evaluation: the complaint lens was received in a different serial number's lens case sn: (b)(6).Visual inspection under magnification revealed that the lens was received cut in half.No defects that could contribute to visual issues were observed.Based on the return condition of the lens no further evaluation could be performed.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: 15381166
• Report Number: 3012236936-2022-02363
• Device Sequence Number: 17554816
• Product Code: HQL
• UDI-Device Identifier: 05050474528932
• UDI-Public: (01)05050474528932(17)260223
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2022

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: 02/23/2026
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2021
• 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 Sex: Unknown