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

Model Number	DIB00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown/not provided.Best estimate date is (b)(6) 2022.If explanted; give date: n/a (not applicable).The lens remains implanted.(b)(4).Device evaluation: the device was not returned at the manufacturing site as it remains implanted; 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 one other complaint has been received for this po; however, the case was not related to the reported complaint issue.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.An attempt has been made to obtain the missing information; however, the consumer did not provide the information.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient with bilateral intraocular lenses (iols) visited his doctor¿s office on (b)(6) 2022, and the patient was told that both lenses were cloudy and would have to be removed.Patient cannot see clearly.Patient is occasionally taking drops for dry eye.Through follow-up, the patient explained that he was not able to see clear and the doctor told him it was due to his pouch being cloudy like a cataract.The patient started noticing the blurry vision right after the right eye was done, may time frame.Therefore, a yttrium aluminum garnet (yag) was performed on both eyes on (b)(6) 2022.The patient confirmed that the initial report "of occasionally taking drops for dry eye" were standard of care drops post surgery.The patient stated that he has had a history of dry eye and thinks it was due to his lasik procedure performed sometime in 1998 prior to iol implant.He has occasionally been taking over-the-counter (otc) eye drops for dry eye.The patient also has had tear duct plugs to help with the dry eyes which were performed sometime in (b)(6) 2022.No other treatments have been provided and the lenses remain implanted.No other information was provided.Patient had bilateral lens implants.This report captures the lens implanted in patient's right eye.A separate report will be filed for the left eye.

• Brand Name: TECNIS SIMPLICITY
• 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: 15578224
• Report Number: 3012236936-2022-02564
• Device Sequence Number: 6801187
• Product Code: HQL
• UDI-Device Identifier: 05050474731660
• UDI-Public: (01)05050474731660(17)240628
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2022

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: 06/28/2024
• Device Model Number: DIB00
• Device Catalogue Number: DIB00U0155
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2021
• 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: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White