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

Model Number	DFR00V
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	11/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ethnicity and race: unknown/ not provided.The device was not received for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.(b)(4).An attempt has been made to obtain the missing information; however, the information was not available.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the patient's left eye due to mechanical failure consisting of spider web glare distortion with distance vision.Account indicated that the lens was removed in one piece.The incision was enlarged; however, no vitrectomy or sutures were required.The iol was replaced with lens model aab00, +17.0 diopter power.The patient is reportedly seeing well and is very happy with the new lens.No further information was provided.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes.Returned to manufacturer on: jan.12, 2022.Section h3.Device evaluated manufacturer? yes.Device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, which is consistent with a lens that was handled during explant.No defects were observed before and after cleaning the lens.The complaint issue could not be confirmed, and no product deficiency could be identified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: upon further review it was discovered that in the initial mdr report, section h6: medical device problem code: code 3191 was coded for unspecified mechanical failure explained in section h10.It was noted that the correct code for this 3191 is supposed to be "no reported device problem".This 2nd supplemental mdr is therefore submitted to correct the explanation on this code in section h10.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: 13182588
• Report Number: 3012236936-2022-00046
• Device Sequence Number: 17182646
• Product Code: HQL
• UDI-Device Identifier: 05050474750593
• UDI-Public: (01)05050474750593(17)240831
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: 2021
• 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,Followup
• Report Date (Section B): 02/24/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• 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: 12/15/2021
• Supplement Date Received by Manufacturer: 02/11/2022; 02/24/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 02/22/2022; 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2021
• 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: 71 YR
• Patient Sex: Male