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 Code	Blurred Vision (2137)
Date of Event	01/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ethnicity: unknown/ not provided.(b)(4).Device evaluation: the device was not returned at the manufacturing site; 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.The search revealed that no similar complaint for this production order number has been received.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 missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported initially that the doctor performed lasik enhancements on patients with synergy lenses to bring their vision into optimal focus.No other information was received.New information was recently received that the intraocular lens (iol) was explanted from the patient's left eye.An unplanned vitrectomy was required.Explant was due to patient visual issues still there/blurry vision and patient stated that the over-all quality of vision was terrible despite yttrium aluminum garnet (yag) done.A non-johnson & johnson lens was implanted as a replacement.It was noted that the patient was ok post-operatively (op).No other information was provided.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes returned to manufacturer on: sep.19, 2022 section h3.Device evaluated manufacturer? yes device evaluation: the complaint lens was received cut in half which is consistent with a lens that was handled during explant.No further defects that could contribute to visual issues were observed.Based on the return condition of the lens no further product evaluation could be performed.The complaint issue ¿hm-blurry vision¿, ¿was not confirmed.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.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: 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: 15280882
• Report Number: 3012236936-2022-02071
• Device Sequence Number: 7054705
• Product Code: MFK
• UDI-Device Identifier: 05050474750685
• UDI-Public: (01)05050474750685(17)240330
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2022

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: 03/30/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/28/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2021
• 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: 63 KG
• Patient Race: Asian