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 Code	Halo (2227)
Date of Event	02/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from a patient's operative eye in a secondary surgical procedure as the patient was dissatisfied with halos.A non-johnson and johnson lens of 21.0 diopter was used as the replacement iol.No further information was provided.
Additional Manufacturer Narrative
Section a2, a4 and a5: unknown, information not provided.Section b3: date of event: unknown, not provided, but the best estimate date is between (b)(6) 2021 and (b)(6) 2022.An attempt has been made to obtain missing information; however, to date, 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 a2: age/date of birth: 70 yrs / (b)(6) 1951; section d9: device available for evaluation? yes; section d9: returned to manufacturer: yes; section d9: date returned to manufacturer: apr 27, 2022; section h3: device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the lens was received cut into four pieces.The lens was cleaned and, no further issues were observed with the lens.Based on the return condition of the lens, no further product evaluation could be performed on the lens.Manufacturing record review: the manufacturing records for the device were reviewed and the product was manufactured and released according to specification.The search in complaint history revealed one additional complaint was received for the product order number; however, this complaint was not confirmed based on the investigation.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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: 14274776
• Report Number: 3012236936-2022-01178
• Device Sequence Number: 5842692
• Product Code: HQL
• UDI-Device Identifier: 05050474750685
• UDI-Public: (01)05050474750685(17)240919
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2022

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: 09/19/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2022
• 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: 04/05/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2021
• 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: 70 YR
• Patient Sex: Female