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

Model Number	AAB00
Medical Device Problem Codes	Contamination (1120); Material Opacification (1426)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If implanted; give date: not applicable, lens was removed and replaced in the same procedure.If explanted; give date: not applicable, lens was removed and replaced in the same procedure.Phone: (b)(6).First name: not provided.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after implantation a glistening was noted in one half of the intraocular lens (iol) optic, but no lens damage was visible.The lens was removed and replaced.The material is available, and no patient issues were reported.No additional information was provided.
Additional Manufacturer Narrative
Corrected information: section h6 - medical device problem code: 1426 - inclusions.Additional information: section h3 - device evaluated by manufacturer? yes.Device evaluation: the intraocular lens (iol) has not yet been returned for evaluation.Therefore, a failure analysis of the complaint device could not be performed.The investigation will be re-opened and a follow-up report submitted in case material is received subsequently.Manufacturing record evaluation: the manufacturing records for the intraocular lens were reviewed.The product was manufactured and released according to specification. a search revealed that no additional complaints for this order number have been received.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Corrected data: in review of section e in follow-up 1, the country was inadvertently selected as united states, however, the country should have been germany.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Additional Manufacturer Narrative
Section d9 - device available for evaluation? yes section d9 - returned to manufacturer? 3/5/2021 section h3 - device evaluated by manufacturer: yes.Device evaluation: visual inspection under magnification revealed that the lens was received cut in half, which is consistent with a lens that was handled during removal and replacement.The lens was received submerged in a solution full of debris.The lens was visually inspected and lens damage was observed (appeared to be an imprint from handling the lens with forceps), but no inclusions (glistening) were observed.Since no inclusions were observed the lens was not sent to eag laboratories for further analysis.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.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: SENSAR 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: 11153077
• Report Number: 2648035-2021-07035
• Device Sequence Number: 3878196
• Product Code: HQL
• UDI-Device Identifier: 05050474548602
• UDI-Public: (01)05050474548602(17)240616
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: consumer,foreign,health profe
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/19/2021

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: 06/16/2024
• Device Model Number: AAB00
• Device Catalogue Number: AAB0000170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 01/19/2021; 03/08/2021; 04/22/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 02/16/2021; 03/12/2021; 05/19/2021
• 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, UNKNOWN MODEL AND LOT#