MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; INTRAOCULAR LENS

Model Number	ZCU150
Medical Device Problem Codes	Material Fragmentation (1261); Use of Device Problem (1670); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Received report indicating the intraocular lens (iol) was fully inserted into the patient¿s left eye.When the iol was inserted the haptic was folded onto the optic and was cut off.The haptic was detached/missing.Customer added that this is a loading issue.The iol was removed and replaced with a non-jnj lens.The outcome does not significantly interfere with activities of daily life.Reportedly, the patient has recovered.No further information is available.
Additional Manufacturer Narrative
Patient weight: unknown/no information.Patient ethnicity and race: unknown/no information.Implant date if implanted; give date: not applicable.The iol was removed/replaced in the initial surgery.Explant date if explanted; give date: not applicable as the iol was removed within the same procedure.Initial reporter name and address email address: unknown/no information.Mfr site telephone number (b)(4).Device evaluation: the product testing could not be performed because the product was not returned.The complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated, and no deviation was found during process related to the complaint issue reported.A search of complaints revealed no other complaints have been received for this production order number.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.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: date returned to manufacturer: june 08, 2021.Section h3: evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed viscoelastic residue on the optic body and haptics and that the lens was received cut into five pieces, which is consistent with a lens that was handled during removal and replacement.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 records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no additional complaints were received for 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.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 MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• MDR Report Key: 11770544
• Report Number: 9614546-2021-07122
• Device Sequence Number: 11536068
• Product Code: HQL
• UDI-Device Identifier: 05050474657717
• UDI-Public: (01)05050474657717(17)250212
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• 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): 07/04/2021

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: 02/12/2025
• Device Model Number: ZCU150
• Device Catalogue Number: ZCU150U160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 07/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE PLATINUM 1MTEC30
• Patient Age: 68 YR