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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female patient was implanted with a synergy intraocular lens (iol) three months ago.The quality of the patient's vision has been poor since the surgery, and worse than pre-operative (op).Surgeon can get her to 20/25 very slowly, but worse than pre-op and worse than left eye (os) with cataract.Surgeon cannot find anything wrong with the eye, and plans on doing a lens exchange.Cornea: patient had lasik, but cornea was clear with normal mires, and spherical.The implant is well centered, optical coherence tomography (oct) is normal macula, the capsule is mild opacity which is not significant, and the surgeon does not want to do a yttrium aluminum garnet (yag) if they are going to exchange the lens.Through follow-up, it was learned the iol was explanted from the patient's right eye.Another johnson & johnson lens, model dib00 19.0 diopter was implanted as a replacement.No other information was provided.
Additional Manufacturer Narrative
Information unknown/not provided.Date of event: exact date unknown/not provided.Best estimate date is 3-4 months ago (february - march 2022).Brand name: unknown only provided as synergy, the serial number was not provided.Model number: unknown, as the serial number was not provided.Catalog number: unknown, as the serial number was not provided.Serial number: unknown, as information was not provided.Expiration date: unknown, as the serial number was not provided.Udi number: unknown, as the serial number was not provided.If implanted; give date: unknown/not provided.Best estimate date is 3-4 months ago (february - march 2022).Establishment name: unknown/not provided.Address, city, state, zip code: unknown/not provided.Telephone number: unknown/not provided.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.Device manufacture date: unknown, as the serial number was not provided.(b)(4).Attempts have been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional info: through follow-up the account information and product information has been provided.Therefore, the following fields that were previously reported as unknown have now been updated accordingly.The following section has been updated accordingly: section d1: brand name: (b)(6) section d4: model number: dfr00v.Section d4: catalog number: dfr00vu190.Section d4: serial number: (b)(6).Section d4: expiration date: aug 11, 2024.Section d4: udi number: (b)(4).Section e1: establishment name: (b)(6).Section h4: device manufacture date: aug 11, 2021.Corrected data: through follow-up, the product identifiers were provided, therefore, this supplemental filing is to correct sections d2.The following section has been updated accordingly: section d2: common device name: intraocular lens section d2: device product code: hql.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: 14881806
• Report Number: 3012236936-2022-01732
• Device Sequence Number: 5048405
• Product Code: HQL
• UDI-Device Identifier: 05050474750654
• UDI-Public: (01)05050474750654(17)240811
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/25/2022
• 2 Devices were Involved in the Event: 1 2

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: 08/11/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU190
• 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: 06/27/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• 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: Female