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

Model Number DFR00V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Halo (2227)

Event Date 05/26/2022

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that after the intraocular lens (iol) was implanted into the left eye, the patient complained of halos.The iol was explanted.A non-johnson & johnson iol of the same diopter power was implanted as a replacement lens.No medical or surgical interventions were required or planned.There was no patient injury reported.The patient is doing well post-operatively.No further information was provided.

Manufacturer Narrative

Additional information: section d9: device available for evaluation? yes section d9: date returned to manufacturer: sep 19, 2022 section h3: evaluated by 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 ¿halo 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.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Type of Device: 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: 15279195
• MDR Text Key: 298457468
• Report Number: 3012236936-2022-02185
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474750692
• UDI-Public: (01)05050474750692(17)240818
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White