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	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted, give date: not applicable, as lens was removed/replaced during the same procedure.If explanted, give date: not applicable, as lens was removed/replaced during the same procedure.Email address: unknown/ not provided.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
Fully inserted lens was removed and replaced in the same procedure due to the trailing haptic being bent.Unable to rotate position lens with bent haptic.Physician put in new (same model) lens and cut damaged lens out.Removed lens in 2 pieces.No other information was provided.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes.Section d9: date returned to manufacturer: jul 20, 2021.Section h3.Device evaluated by manufacturer? yes.Device evaluation: visual inspection under magnification revealed that the lens was received cut in half and viscoelastic residue on the optic body and haptics, which is consistent with a lens that was handled during removal and replacement.A detached haptic was also observed.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no additional complaints were received from this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.

• 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: 12125380
• Report Number: 2648035-2021-08101
• Device Sequence Number: 3712802
• Product Code: HQL
• UDI-Device Identifier: 05050474528895
• UDI-Public: (01)05050474528895(17)250928
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

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: 09/28/2025
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 08/22/2021
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1