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	Blurred Vision (2137); Halo (2227)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Pt info: unknown/no information available.Date of event: the exact date is unknown, the best estimate is after the implant date (b)(6) 2021 and (b)(6) 2021 which is the explant date.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was implanted into the patient¿s left eye.The patient experienced blurry vision and halos.The customer considers the delay in procedure approximately 10 months later when the explant took place.The iol was explanted and replaced with a non johnson & johnson lens.There was no incision enlargement, sutures, or vitrectomy required.No further information was provided.
Additional Manufacturer Narrative
Additional information section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: nov 30, 2021.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the lens was received cut in half and a haptic detached, which is consistent with a lens that was handled during explant.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed.A product quality deficiency could not be determined.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no other complaints were received for this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be 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 ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12783968
• Report Number: 2020664-2021-07786
• Device Sequence Number: 5155794
• Product Code: HQL
• UDI-Device Identifier: 05050474529007
• UDI-Public: (01)05050474529007(17)250924
• 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
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 01/14/2022

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: 09/24/2025
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• 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: 10/14/2021
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 11/09/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2020
• 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 Sex: Male
• Patient Weight: 116 KG