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

Model Number	ZXR00
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: n/a (not applicable).Lens was removed/replaced during the same procedure.If explanted; give date: n/a (not applicable).Lens was removed/replaced during the same procedure.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a tecnis symfony intraocular lens (iol) was fully inserted but would not unfold in the patient's left (os) eye.The lens was removed and replaced with a back up lens during the same procedure.There was no additional surgical intervention performed.The patient outcome was not provided.No further information provided.
Additional Manufacturer Narrative
The following sections are updated per new information obtained in product investigation: section d6a: implant date: give date: 6/28/2021.Section d9: device available for evaluation: yes section d9: return to manufacturer: 8/26/2021 section h3: device evaluated by manufacturer: yes device evaluation: the product was returned and evaluated.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that a haptic was stuck to the optic body, which can be attributed to handling and also the viscoelastic residue drying off and sticking the haptic to the lens and therefore cannot be confirmed to be related to manufacturing.The lens was cleaned, and the haptic became unstuck from the optic body.No further issues were observed.The complaint issue could not be confirmed (dc-haptic stuck to optic is similar to the complaint issue however unfolding issues cannot be confirmed without a recording of the procedure), and no product deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.Historical data analysis: a search of complaints revealed a complaint which is a voided duplicate of event in this file and therefore no further escalations are required.Conclusion: as a result of the investigation, there is no indication of a quality product 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
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 12263815
• Report Number: 2648035-2021-08243
• Device Sequence Number: 3635989
• Product Code: POE
• UDI-Device Identifier: 05050474579101
• UDI-Public: (01)05050474579101(17)230914
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 75