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

Model Number	ZA9003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.(b)(4): the device was not returned for analysis as the lens was discarded.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 or Problem Description
It was reported that the haptic of the intraocular lens (iol) broke.The lens was fully inserted into patient's left eye and was removed and replaced with another lens of same model and diopter (b)(4) during the same procedure.However, there was no patient injury and no intervention was required.No further information was available.
Additional Manufacturer Narrative
Section d9: device available for evaluation: yes section d9: returned to manufacturer on: june 10, 2021 section h3: device evaluated by manufacturer: yes device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed viscoelastic residue on the optic body and haptics, which is consistent with a lens that was handled during implanting.The lens was cleaned, haptic damage (bent) and a detached portion of the same haptic were observed, but these may be attributed to handling and cannot be confirmed to be related to manufacturing.The complaint issue was confirmed; however, this can be attributed to handling and cannot be confirmed to be related to manufacturing, and therefore no product deficiency could be identified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification.The search revealed no additional investigation request (ir) for this production order number has been received.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
• MDR Report Key: 11963235
• Report Number: 2648035-2021-07922
• Device Sequence Number: 14520338
• Product Code: HQL
• UDI-Device Identifier: 05050474528840
• UDI-Public: (01)05050474528840(17)250606
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 07/22/2021

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: 06/06/2025
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 06/08/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 64