MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; INTRAOCULAR LENS

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Halo (2227)
Date of Event	08/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from a patient's left eye in a secondary surgical procedure as patient¿s vision had not improved; they felt like they were ¿looking out of the bottom of a coke glass".The patient complained of "hazy halo" when looking at points of light and indicated that the lens eye vision is "depressing".The patient did not like the quality of their vision with the synergy lens, was unhappy and reportedly they would not be satisfied with their vision even if they are plano refraction.A non-johnson and johnson lens of 21.0 diopter was used as the replacement.Anterior vitrectomy was performed during the explant.There was no patient injury, and the outcome was reported to be good; ¿vision is doing great¿.No further information was provided.
Additional Manufacturer Narrative
Ethnicity: unknown, it was asked, but the information was not provided.Attempts were made to obtain missing information; however, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes section d9: returned to manufacturer: yes section d9: date returned to manufacturer: mar 16, 2022 section h3: device evaluated by manufacturer: yes device evaluation: the complaint lens was received stuck to a piece of styrofoam.No other product was received.Visual inspection under magnification revealed that the lens was received cut in half.The lens was cleaned and, no issues related to or could have contributed to visual issues were observed.Manufacturing record review: the manufacturing records review for the production order shows that the units were released within specification.The search in complaints revealed one additional complaint for this production order number; however, the complaint was not confirmed.Conclusion: as a result of the investigation there is no indication of a product deficiency or product malfunction.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 MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 14032132
• Report Number: 3012236936-2022-00888
• Device Sequence Number: 6301123
• Product Code: HQL
• UDI-Device Identifier: 05050474750692
• UDI-Public: (01)05050474750692(17)240401
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 05/19/2022

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: 04/01/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• 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: 03/08/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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 Age: 48 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Race: White