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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138); Halo (2227); Capsular Bag Tear (2639)
Type of Reportable Event	Serious Injury
Event or Problem Description
Received report from a female patient who had a johnson and johnson intraocular lens (iol) implanted in both eyes.She experienced blurry vision, decreased visual acuity and glows/halos.At approximately 10 feet her vision starts to become blurry.With rain the glow on the ground is whitish or greyish.The patient explained that prior to the implant her vision was 20/20 but after the implant it is 20/70 and has decreased visual acuity in both eyes.Regarding her right eye, the doctor said there is rippling in the capsule.Initially the doctor thought the rippling would resolve on its own but eventually had to perform laser surgery.In relation to her left eye she reported the same symptoms but no rippling.However, the pupil in her left eye is not centered.Reportedly, the doctor did not say why the pupil is decentered.Both eyes had laser surgery performed around (b)(6) 2022.She continues to have nighttime glow, blurry vision and needs to wear glasses due to her decreased visual acuity.Although the glasses resolve her vision issues, the patient reiterated that she never needed glasses prior to the implant.The only medication she is on is ketorlac eye drops twice a day.No further information was provided.This medwatch captures the right eye.The left eye is reported in medwatch 3012236936 - 2022 - 02406.
Additional Manufacturer Narrative
If explanted, give date: not applicable, as lens remains implanted.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 records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no additional complaints were received for this po.Conclusion: a product deficiency has not been identified; therefore, no additional corrective actions have been initiated.Attempts have been made to obtain the missing information.However, to date it has not been received.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 15525029
• Report Number: 3012236936-2022-02405
• Device Sequence Number: 16790257
• Product Code: MFK
• UDI-Device Identifier: 05050474750647
• UDI-Public: (01)05050474750647(17)241115
• 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): 09/30/2022

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: 11/15/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU185
• 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: 09/08/2022
• Initial Report FDA Received Date: 10/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2021
• 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
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White